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Comparison of gentian violet application and moisture vapour permeable dressings for the management of… Korabek, Barbara Joyce 1994

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COMPARISON OF GENTIAN VIOLET APPLICATION AND MOISTURE VAPOUR PERMEABLE DRESSINGS FOR THE MANAGEMENT OF OPEN SKIN LESIONS SECONDARY TO RADIATION THERAPY FOR HEAD AND NECK CANCER  by  BARBARA JOYCE KORABEK Diploma in Nursing, Mount Royal College, 1976 BScN., University of Alberta, 1986  A Thesis Submitted in Partial Fulfilment of the Requirements for the Degree of Master of Science in Nursing in The Faculty of Graduate Studies School of Nursing  We accept this thesis as conforming  7/ THE UNIVERSI1* OF BRITISH COLUMBIA September, 1994 Barbara Joyce Korabek  _  presenting this In thesis in partial fulfillment of the requirements for an advanced degree at the University of British Columbia, I agree that the Library shall make it freely available for reference and study. I further agree that permission for extensive copying of this thesis for scholarly purposes may be granted the by head of department my or by his or her representatives. It is understood that copying or publication of this thesis for financial gain shall not be allowed without my written permission.  (Signature)  Department of____________________ The University of British Columbia Vancouver, Canada  Date t2z y/i99  II  ABSTRACT  A randomized controlled pilot study of 9 patients who developed an open skin lesion secondary to radiation therapy for primary head and neck cancer was initiated. The purpose of this pilot study was to examine and compare the effectiveness of gentian violet (GV) and moisture vapour permeable dressing (MVPD) in promoting healing and reducing discomfort at an open lesion site secondary to radiation therapy. Patients were randomly assigned to either the gentian violet or moisture vapour permeable dressing group at the time of lesion onset. The skin care treatments were evaluated with respect to the rate of lesion healing and discomfort levels at the lesion site. Data were collected using two forms specifically designed for this study. Nine subjects completed the study. All patient’s skin lesions healed with no evidence of infection in any of the lesions. The results of the study, statistically analyzed using the Mann-Whitney U test with  =  0.05, supported the two hypotheses proposed in this study.  Lesions treated with MVPD demonstrated a significantly faster healing rate than did those treated with GV ( U  =  8,  =  0.05). The results also indicated the  patients treated with MVPD experienced significantly lower levels of burning, itchiness, pulling and tenderness (U  =  9,  <  0.001) at the lesion site 24  hours after starting the study and when their lesions were at maximum size.  III  Although the sample was small the results of this study tend to indicate that in the clinical practice setting, MVPD can be used effectively as a treatment for skin lesions, secondary to RT, involving the epidermal and portions of the dermal layers of the skin.  iv Table of Contents Abstract  ii  Table of Contents  iv  List of Tables  vii  List of Figures  viii  Acknowledgements  ix  CHAPTER ONE: INTRODUCTION Background to the Problem Problem Statement Purpose Conceptual Framework Hypotheses Definition of Terms Open Skin Lesion Secondary to Radiation Therapy Complete Lesion Healing Discomfort at the Lesion Site Gentian Violet Moisture Vapour Permeable Dressing Significance of the Study Organization of the Thesis  1 3 3 3 7 7 7 8 8 8 9 9 10  CHAPTER TWO: REVIEW OF THE LITERATURE Introduction The Skin Head and Neck Cancer Radiation Therapy and Its Effect on the Skin Assessment of Skin Reactions to Radiation Treatments of Radiation Induced Skin Reactions Moisture Vapour Permeable Dressings Gentian Violet Summary of the Literature Review  11 11 14 15 17 19 20 24 26  V  CHAPTER THREE: METHODS Introduction Research Design Selection Criteria Instruments for Data Collection Pre-test Procedures Data Analysis Procedures Assumptions Limitations Procedure for the Protection of Human Rights Summary of the Methods  27 27 27 29 33 33 35 36 37 37 38  CHAPTER FOUR: PRESENTATION AND DISCUSSION OF FINDINGS Introduction General Characteristics of the Sample Socio-demographic Characteristics Medical and Radiation Therapy Characteristics Skin Condition at Lesion Onset and Maximum Lesion Size Discomfort Level at Lesion Onset Equivalence of the Groups Hypothesis One: Regarding Rate of Healing Hypothesis Two: Related to Discomfort Levels Discussion Findings Related to the Hypotheses First Hypothesis Second Hypothesis Methodological Considerations Representativeness of the Sample Equivalence of the Study Groups Evaluation of the Study Outcomes Summary  39 39 39 40 42 43 45 45 49 53 57 57 58 60 60 60 61 63  CHAPTER FIVE: SUMMARY, CONCLUSION, IMPLICATIONS, AND RECOMMENDATIONS Introduction Summary Conclusions Implications Recommendations for Further Research  66 66 68 68 71  vi 73  REFERENCES APPENDIXES Appendix Appendix Appendix Appendix Appendix Appendix Appendix Appendix Appendix Appendix Appendix  A. Smith and Nephew Flexigrid B. Assessment Flow Sheet C. Skin Care Protocol GV D. Skin Care Protocol MVPD E. Personal and Medical History Form F. Grade of Healing G. Colour Groupings Measurement Erythema H. Exudate Groupings I. Patient Information and Consent Form J. Skin Culture Procedures K. Procedure for Photographs  79 80 81 82 83 84 85 86 87 90 91  vii List of Tables  Table Page 1  The Skin Reaction to Radiation Grading Scale  19  2  Products Used in the Care of Radiation Induced Skin Reactions  21  Demographic, Radiation Therapy and Medical Characteristics of the Sample  41  Skin Lesions Characteristics at Onset and Maximum Lesion Size  44  Erythema and Exudate Characteristics at Lesion Onset and Maximum Lesion Size  45  Levels of Discomfort at Three Time Periods During Study  46  Healing Rates From Onset and Maximum Lesion Size to Complete Healing  49  Duration of Healing in Days in Terms of Grade of Healing  51  3  4  5  6  7  8  VIII  List of Figures Page  Figure Diagram of the Structure of the Human Skin  12  II  Design of the Study  28  III  Level of Burning at Lesion Onset, 24 hours on Study and When Lesion was at Maximum Size  52  Level of Itchiness at Lesion Onset, 24 hours on Study and When Lesion was at Maximum Size  54  Level of Pulling at Lesion Onset, 24 hours on Study and When Lesion was at Maximum Size  55  Level of Tenderness at Lesion Onset, 24 hours on Study and When Lesion was at Maximum Size  56  IV  V  VI  ix Acknowledgements  I would like to thank the members of my thesis committee, Dr. Ann Hilton (chairperson), Dr. Michelle Deschamps and Professor Anne Wyness for their patience and guidance throughout the past years. I wish to extend a special thanks to Zdenek, my husband, for continuing to be a source of encouragement and support. I wish to thank all the staff on the 5th floor and the Surgical Suite at BCCA, for their patience and understanding until I finished this project. Finally, I would like to acknowledge the individuals who so generously took the time to participate in this study.  1  CHAPTER ONE Introduction Background to the Study Approximately 400 patients are diagnosed with head and neck cancer yearly in British Columbia (British Columbia Cancer Agency, 1992).  In the  course of their disease, the majority of these patients will receive radiation therapy (RT) either as a primary treatment to cure the disease or as a palliative measure for symptom management (Strohl, 1988).  Radiation affects both  normal and cancerous tissue, producing skin reactions which vary from mild erythema to open skin lesions.  To date there is no precise data on the  incidence of open skin lesions for head and neck tumour patients. However, it is estimated that at least 25% of these patients will experience a radiation induced skin reaction (RISR) that will result in some degree of tissue loss (Fajardo & Berthrong, 1981). Several treatment modalities are proposed to care for RISR (Franklin, 1991; Margolin, Breneman, Deman, LaChapelle, Weckback & Aron, 1990; McGowan, 1989; Shell, Stanuta & Grimm, 1986; Walker, 1982). In British Columbia, one of the treatments used for open skin lesions secondary to RT is the application of 1 % Gentian Violet (GV) solution several times a day to the affected skin area (British Columbia Cancer Agency, 1992). Although no studies have specifically documented the properties of GV in RISR, it is assumed that this agent, in  2 addition to promoting drying of the exudate, has antifungal and antibacterial effects (Springhouse Corp., 1991) (Sitton, 1992).  The benefit of the first  property has, however, been questioned by several authors (Hassey & Rose, 1 982; Ratliff, 1 990; Walker, 1 982) who believe that dryness of an open skin lesion may inhibit the regeneration of the epidermis by limiting cell movement that occurs during healing (Hassey & Rose, 1982; Winter, 1964). In addition, some patients find the use of GV to be messy, staining, uncomfortable and difficult to manage (Sitton, 1992). The availability of Moisture Vapour Permeable Dressing (MVPD) has offered the possibility of a new approach in the care of open skin lesions secondary to RT.  MVPD (Bioclusive, Op-Site, Tegaderm) are polyurethane clear film  dressings permeable to oxygen and water vapours and impermeable to liquid and bacteria (Barnett, Berkowitz, Mills & Vistness, 1985). The healing property of MVPD in clean open skin lesions (graft donor sites, surgical incisions and superficial pressure sores) has been documented (Barnett et al, 1983; Dinner, Peter & Shever, 1 979; James & Watson, 1 975; Moshakis, Fordyce, Griffiths & McKinna, 1 984). In these cases, MVPD have been found to decrease the bacterial contamination and incidence of infection and to accelerate the healing process (Dinner et al 1979; James et al 1975; Winter, 1962).  In addition,  patients have found MVPD comfortable. Based on these observations, as well as on the results of their own study, Shell et al (1986) postulated that if MVPD were used in the care of open  3 skin lesions secondary to RT they would demonstrate the same beneficial effects as those seen with other partial skin loss lesions. Although MVPD have been used in other centres in the care of open skin lesions secondary to RT, they have not been used in British Columbia for this purpose. No studies to date have been undertaken to examine and compare the use of GV and MVPD in terms of promoting healing of open skin lesions secondary to RT for head and neck cancer or reducing discomfort at these lesion sites. Problem Statement Various methods of treatment have been suggested for the care of open skin lesions secondary to RT. Both GV and MVPD are currently used to treat open skin lesions secondary to RT. To date, no studies have examined their effectiveness in promoting lesion healing and minimizing the level of discomfort at the lesion site. Purrose The purpose of this pilot study was to examine and compare the effectiveness of GV and MVPD in promoting healing of skin lesions secondary to radiation therapy and reducing discomfort at these lesion sites. ConceDtual Framework The healing process of an open lesion, hereafter referred to as lesion, and the factors that influence the course of healing have provided the underlying conceptual framework for this study. The healing process is a fundamental  4 defense mechanism to protect the body against foreign microorganisms and to replace the lost tissue (Hunt & Dunphy, 1979). When the integrity of the skin is disrupted and a lesion is created, a series of dynamic events are enacted.  Initially the lesion is invaded by  polymorphs as well as macrophages which debride the lesion surface preparing it for the subsequent events of the healing process (Cunon, 1985). Depending upon the extent of the lesion, two different mechanisms of healing exist; regeneration or replacement of the damaged tissue.  Regeneration is the  substitution of lost tissue with tissue of a similar type, whereas replacement is the substitution of the lost tissue with new connective tissue (Cunon, 1985; Doughty, 1 992). The type of tissue repair or healing depends on the ability of the tissues involved to regenerate; the epidermis and dermis layers of the skin have the capacity for regeneration. The rationale for this is that epithelial, endothelial, and connective tissue within these layers of the skin can be reproduced  (Doughty,  1 992).  Epidermal  and  dermal  repair  proceed  concurrently; epidermal by reepithelialization and dermal by collagen repair (Doughty, 1992).  The critical event in the process of regeneration is the  reepithelialization or reestablishment of the normal skin layers and function (Doughtly, 1 992). The salient feature of reepithelialization is that it takes place primarily by cell movement (Winter, 1 964); the cells migrate across the open lesion until the lesion is closed.  The process of reepithelialization can be  visually observed. It is a process the moves from a state of no epithelialization,  5 to spotty small areas, to larger areas and finally to complete reepithelialization or complete lesion healing (Cunon, 1985). This process is dependent of the ability of the cells to migrate across the lesion bed. The migration of these cells is more rapid in a controlled moist environment rather than a dry one. When a more extensive injury is present, complete loss of the epidermis, dermis and deeper structures, such as subcutaneous tissue, a less precise process of healing occurs referred to as “replacement” of tissue. Tissue replacement is the reconstruction of lost tissue with new connective tissue (Cunon, 1985). Several factors may influence the healing process. For example, at a cellular level the presence of an infectious state, excessive moisture or dryness in the lesion bed, and the intake of steroids interfere with the inflammatory responses and the reepithelialization of the tissues (Doughty, 1992).  At a  systemic level, an advancing age, impaired nutritional status, and vascular insufficiency decrease the energy and oxygen supply necessary for the biochemical reactions that are part of the healing process (Cunon, 1 985). Radiation exposure, which is the main focus of this study, creates an open skin lesion and then interferes with the healing process by: (1) disrupting the balance between basal cell production and surface cell destruction; (2) decreasing the mitotic production rate; (3) shortening the cell cycle time; and (4) limiting cellular movement by first creating a dry lesion and then an excessively moist lesion thereby limiting cellular movement and promoting bacterial proliferation (Hassey, et al, 1982).  Continued daily exposures to  6 radiation results in observable epidermal and dermal skin reactions which vary from alteration in the skin’s pigmentation, to a reddening of the skin, referred to as erythema, and finally to the appearance of open skin lesions (Hassey et al, 1982). The healing process of a lesion can be enhanced by various means such as protecting the lesion against contamination, friction and trauma; maintaining a clean moist environment; and by ensuring adequate oxygen, nutrition and fluid levels (Doughty et al, 1992). GV enhances healing by acting as a topical pharmacological agent to control superficial skin bacteria and fungi growth. MVPD, on the other hand, acts at two levels: first, by creating and maintaining a clean moist protective barrier that  enhances  cellular  migration  and  limits  external  bacterial  contamination, (Doughty et al, 1988; Winter, 1964), and then by protecting against friction, thereby reducing the chance of further abrasive damage and its associated discomfort. In this study these two treatment interventions, both of which are directed towards enhancing the healing process, were compared. Lesions resulting from RT are frequently described in the literature as being tender and uncomfortable for patients (Malkinson & Keane, 1981; Wang, 1991). The reason for this is that when these lesions are created the nerve endings are abraded and exposed to the external environment producing varying levels of discomfort.  Evaluating the effectiveness of a particular skin care  treatment without determining its effects on the patient’s level of discomfort  7 would only half measure the quality of the treatment. The treatment technique utilized to promote the healing process must also consider maintaining or decreasing the level of discomfort to be an effective treatment strategy. Hypotheses The hypotheses tested in this pilot study were the following: 1. Open skin lesions secondary to radiation therapy in head and neck cancer patients treated with MVPD will heal at a faster rate than those treated with GV. 2. Head and neck cancer patients with an open skin lesion receiving treatment with MVPD will describe less discomfort at the open lesion site than patients who receive treatment using GV. Definition of Terms  ODen Skin Lesion Secondary to Radiation Therapy An open skin lesion is an observable skin loss that occurs when the skin is exposed to RT (Bloomer & Hellman, 1975; Hassey et al, 1 982; Malkinson & Keane, 1981; Wang, 1 991). In this study, the size of the lesion was measured in squared centimetres using the Smith and Nephew Flexigrid (Appendix A) and was documented on the Assessment Flow Sheet developed for this study (Appendix B).  8  ComDlete Lesion Healing Complete lesion healing is the complete reepithelialization of a lesion (Doughty, 1 992). Evaluation of healing was done by measuring the lesion size and the rate of reepithelialization until complete healing had occurred. Healing rate was determined in days, from the first day an open lesion was observed until the day it was completely healed.  Reepithelialization was graded on a  scale of 1 to 4: (1) no epithelialization or healing present; (2) the presence of spotty sparse regions of epithelialization; (3) the presence of larger areas of epithelialization (the small spotty areas are grouping together to form larger areas); and (4) the presence of complete reepithelialization or complete healing (Cunon, 1985). Discomfort at the Lesion Site Discomfort is a subjective experience reported by patients when asked to describe their sensations at a lesion site secondary to RT.  In this study,  discomfort was assessed by measuring the degree of burning, itchiness, pulling, and tenderness experienced by the patient at the lesion site using a visual analogue scale. The results were documented on the Assessment Flow Sheet developed for this study (Appendix B). Gentian Violet Methylrosaniline chloride 1 % (gentian violet) is an antifungal and antibacterial solution that is applied directly to the skin.  9 Moisture Vapour Permeable Dressing Moisture Vapour Permeable Dressing is a sterile film dressing made of polyurethane covered with a hypoallergenic adhesive on one side.  In this  study, the MVPD used was Flexigrid Op-site manufactured by Smith and Nephew. Significance of the Study  Scientific Significance The information obtained from this study supplements the knowledge concerning the appropriate strategies for the care of open skin lesions secondary to radiation therapy. The study provides the information required to determine the feasibility and merit of conducting a larger study. Practical Significance Nursing is taking a more active role in the determination of care strategies for RISR but to date, little scientific evidence is available to guide clinical practice.  This pilot study attempted to systematically evaluate two  current methods used in the care of open skin lesions secondary to RT, with respect to their ability to promote healing, decrease the severity of the level of discomfort experienced by patients, and improve their quality of life. The findings of this study will provide knowledge about the healing process of lesions secondary to RT. Included in this knowledge will be specific information on how moist versus dry skin care treatments actually facilitate the  10 healing process and at what stage in the healing process the benefits are most likely to be seen. In addition, the findings will provide knowledge about two types of skin care treatments and the patient’s level of discomfort throughout the healing process. This knowledge will assist nurses on how best to treat open skin lesions secondary to RT with the outcomes of promoting healing and decreasing the discomfort experienced by the patient. Finally, the results of this study will add to the general knowledge related to lesion healing, and how RT affects the skin and the healing process. Organization of the Thesis This thesis is comprised of five chapters. background to  the  problem,  problem statement,  In Chapter One, the purpose,  conceptual  framework, hypotheses, significance of the research, and definitions have been presented. In Chapter Two, a review of selected literature pertaining to the identified research hypotheses will be presented.  In Chapter Three, the  research methods including a description of the research design, data collection tools, procedures as well as means used for protection of human rights and data analysis will be described. In Chapter Four, the description of the sample findings, and a discussion of the results will be presented.  The summary,  conclusions as well as the implications for nursing practice and research will be presented in Chapter Five.  11 CHAPTER TWO Review of the Literature Introduction  The literature review examines both research and non-research based literature. The review is divided into five sections: (1) a brief review of head and neck cancer including its epidemiology and treatment; (2) an overview of the structure and physiology of human skin; (3) details on the effects of radiation on the skin; (4) assessment of the RISR; and (5) a critical review of research on the treatments used in the care of RISR with an emphasis on GV and MVPD in the treatment of open skin lesions. The Skin The skin constitutes a vast protective barrier between man and his environment.  It is one of the largest organs in the body, constituting  approximately one eighth of the weight of a normal individual (Wood & Blada, 1 985). The skin is composed of three recognizable layers: the epidermis, the dermis, and a layer of adipose tissue referred to as the hypodermis (Wood & Blada, 1985) (see figure 1). The epidermis arises from the embryonic ectoderm and forms most of the cutaneous appendages including the sweat and sebaceous glands, the hair, and the nails (Okun, Edelstein & Fisher, 1988; Wood & Blada, 1985).  Several  layers of cells within the epidermis are recognized histologically. These include  12 Figure I. Diagram of the structures of the human skin.  us gland  Sweat Di  rmis  lermis  Sweat gland  Nerve  Adipose  13 the stratum basale, stratum spinosum, stratum granulosum, stratum lucidum and finally the stratum corneum.  The superficial cells of the outermost  corneum layer are shed and are replaced by new cells that are formed continually by mitosis in the basal layer (stratum basale) (Sitton, 1992). Very few other body cells have the capability of continually producing new cells (Wood & Blada, 1985).  The epidermis and dermis are separated by the  basement membrane, which has a major role in regulating epidermal growth through the mechanism of diffusion of nutrients from the dermal blood vessels (Sitton, 1991). The dermis arises from the embryonic mesoderm and supports the cutaneous appendages such as hair follicles, sebaceous and sweat glands. It also contains blood vessels, lymph vessels and nerves (Okun et al, 1 988). The dermis makes up the bulk of the skin and is composed of a network of mechanically strong fibres, mostly collagen. It is a tough, resilient tissue that cushions the underlying organs against mechanical injury and provides nutrients for the epidermis and cutaneous appendages (Okun et al, 1988). The dermis, consists of two specific cells, fibroblasts and macrophages, which are responsible for the production of collagen. Collagen plays a major role in the healing process, specifically in scar formation and granulation. Beneath the dermis is a layer of loose connective tissue referred to as the hypodermis (Wood & Blada, 1985). most of the body  ,  It forms a layer of adipose tissue over  providing thermal insulation, mechanical protection, and  14 energy reserve for the body (Wood & Blada, 1985). Any action or mechanism that disrupts the physiology of the skin can leave the skin susceptible to an Exposure of the skin to ionizing radiatioh disrupts the normal  injury.  physiological activities of the skin making it susceptible to developing an open lesion (Hassey et al, 1982). Head and Neck Cancer Head and neck cancer encompasses oral, larynx, pharynx, thyroid and salivary gland cancers (British Columbia Cancer Agency, 1992). The etiology of these cancers is unknown but they appear to be more common amongst smokers and alcohol drinkers (Schottenfeld & Fraumeni, 1982). Head and neck cancers are found in both genders; the male/female ratio is 2-3:1 in most countries (Schottenfeld & Fraumeni, 1 982). Generally, the medical treatment for these cancers includes surgery, RT and chemotherapy (King, Nail, Kreamer, Strohl, & Johnson, 1985; Kusler, & Rambur, 1992). cancers  ,  In early squamous cell  for example, the preferred primary treatment is RT.  involvement of the lymph nodes is detected, surgical dissection  But when ,  usually  followed by RT, may be recommended. It is only after radiation and radical surgery have failed that chemotherapy is added to the treatment plan in most situations (Wang, 1991). Therefore, the majority of patients with head and neck cancer will receive RT at some stage of their disease, placing them at risk for developing a RISR. RT for head and neck tumour patients is usually given on a 5 day on and  15 2 day off schedule over a 4 to 6 week period. The total dose of radiation is between 4,000 and 7,000 cGy (British Columbia Cancer Agency, 1 992). The loss of taste and appetite as well as mucositis, fatigue, sore throat, hoarseness and dysphasia are among the common side effects associated with RT (King et al, 1985; Wang, 1991; Woodtil & Van Ort, 1991).  However, one of the  major side effects observed in patients is varying types of skin reactions (King et al, 1985; Wang, 1991). The character and magnitude of the RISR depends upon many factors including the anatomical site, the quality of the radiation and ionization density, total dose of radiation, number of fractions, size of tissue irradiated, vascular supply, as well as the age and general condition of the patient (Bloomer & Hellman, 1975; Malkinson & Keane, 1981; Walker, 1982). Radiation Theraiw and Its Effect on the Skin RT is the ejection of radioactive and electromagnetic particles in tissue or inside the cells in order to treat cancerous tumours (Bloomer & Hellman, 1 975; Malkinson & Keane, 1981). On a cellular level, radiation causes DNA damage which leads to cellular death (Bloomer & Hellman, 1975; Malkinson & Keane, 1981). Radiation affects normal and cancerous cells in essentially the same manner; by attacking cells that have a high mitotic rate, such as skin cells more rapidly.  The principle underlying RT is to destroy the cancerous cells while  leaving sufficient normal cells to enable tissue repair, thereby minimizing the side effects associated with the treatment (Malkinson & Keane, 1981; Walter, 1977).  16 Through a feedback mechanism called homeostatic stimulus, normal skin cells have the ability to repair damage caused by ionizing radiation (Ratliff, 1990).  But this repair process requires extended time intervals between  radiation exposures. The therapeutic level of radiation needed to destroy the cancerous cell growth requires repeated exposures of radiation in a short time interval thereby decreasing the ability of normal cells to repair which results in RISR. Several authors have consistently described the skin’s reaction to RT (Bloomer & Hellman, 1975; Hassey et al, 1982; Malkinson & Keane, 1981; Wang, 1991). Within the first week of treatment a transient, reddening of the skin or faint erythema appears. This is due to capillary dilation and an increase in vascular permeability (Bloomer & Hellman, 1975).  After the first few  fractions of 200 to 400 cGy, there is an inhibition of mitotic activity in the germinal cells of the epidermis, hair follicles, and sebaceous glands (Bloomer & Hellman, 1 975). Dry desquamation, characterized by pruritus, scaling, and peeling in the basal layer becomes apparent due to the suppression of the sebaceous glands and the rapid basal cell production (Hassey et al, 1982). Often an increase in pigmentation is also observed.  By the third or fourth  week, a typical bright erythema reaction appears, sharply localized in the radiation field. The skin is red, edematous, warm, and variably tender (Hassey et al, 1982).  Blood vessels in the upper dermis are dilated.  Edema is  prominent, especially in the upper dermis and there may be small foci of  17 haemorrhage (Bloomer & Hellman, 1975). When the dose of radiation exceeds 4,000 5,000 cGy, which is frequently -  the case with head and neck cancers, the erythema is usually followed by a moist desquamation (Malkinson & Keane, 1981; Wang, 1991).  Moist  desquamation is the presence of an open lesion, varying from partial loss of the epidermal to complete loss of the epidermal and dermal layers of the skin that occurs as a result of the inability of the basal cells to provide enough differentiated cornified cells (Malkinson & Keane, 1981). In the past, RISR were a treatment limiting complication, but today With the use of megavoltage radiation sources such as linear accelerators, the skin is generally spared from developing open skin lesions (Fajardo et al, 1981). However, open skin lesions are still observed in some instances. To date, there is no precise data on the incidence of open skin lesions secondary to RT for patients with head and neck cancer.  However, based on the researcher’s  experience it is estimated that the majority of head and neck cancer patients have a reaction that results in some degree of tissue loss during or following the course of their RT. Assessment of Skin’s Reaction to Radiation To date no standardized methods have been developed to assess and quantify the severity of RISR.  Most often, simple descriptions such as  erythema, dry and moist desquamation have been used (Hassey et al, 1 982; Hilderly, 1983; McGowan, 1 989; Ratliff, 1 990; Sitton, 1992; Troetschel,  18 1991; Walker, 1982). Recently, several attempts have been made to classify RISR.  The Clinical Practice Committee of the Oncology Nursing Society in  1 982 described a four level system of impairment which ranges from a potential impairment to the presence of an open purulent skin lesion. Yasko, (1983) on the other hand, established a staging system based on clinical reactions.  Each stage has a corresponding description: Stage I, erythema;  Stage II, dry desquamation; and Stage Ill, moist desquamation. The Radiation Therapy Oncology Group (RTOG), developed a scale titled “The Acute Radiation Morbidity Scoring Criteria” which is also based on clinical reactions. This scale describes five levels of skin reactions ranging from 0 to 4 where 0 indicates no change and 4, an ulcerative, haemorrhagic and necrotic lesion. The above methods have been found useful to describe skin reactions in clinical settings. However, they all lack precision when trying to evaluate the size of an open lesion for research purposes. The scales listed above utilize the broad category of moist desquamation to describe a RISR that has an open skin lesion present.  However, they do not describe specifically the extent or  progression of the tissue damage. Table 1, presents a method that uses a 4 point ordinal scale (Overgaard, Bentzen, Chritensen, & Hjollund, 1987). This scale describes the severity of the skin reaction in detail as well as the progression of the reaction, but still does not mention the amount of tissue loss or size of the open lesion in detail, therefore making it ineffective for this particular study. A more precise method was developed to measure the exact  19 size of the open lesion as well as the degree of reepithelialization present. Table 1 Radiation Induced Skin Reaction Grading Scale Endpoint Moist desquamation Erythema Telangiectasis Subcutaneous fibrosis  Grade 3  Grade 0  Grade 1  Grade 2  None None None  10% Mild 1 cm 2  10%-49% Moderate 1-4 cm 2  50% Severe 4 cm 2  None  Mild  Moderate  Severe  Note. From “The value of the NSD formula in equation of acute and late radiation complications in normal tissue following 2 and 5 fractions per week in breast cancer patients treated with post mastectomy radiotherapy by Overgaard, M. Bentzen, S., Christensen, J. & Hjollund, M., 1987, RadiotheraDy Oncology, 50.  Treatment of Radiation Induced Skin Reactions Various approaches have been described for the treatment of RISR (Farley, 1991; Hassey et al, 1982; Hilderly, 1983; Margolin et al 1 990; Pineau, 1 990; Ratliff, 1 990; Roof, 1991; Shell et al, 1986; Sheriden & Jackson, 1989; Sitton, 1992; Walker, 1 982). Among those outlined are the use of cornstarch to control pruritus, lanolin to provide moisture (Murphy, 1962; Walker, 1982), topical antibiotics to control the occurrence of acute infection (Kelly & Tinsley, 1981; Murphy, 1962; Wilson & Strohl, 1982; Yasko, 1983), topical steroids to reduce itchiness (Kelly et al 1981; Wilson, 1982; Yasko, 1992), and hydrocolloid dressings to control the lesion exudate (Margolin et al, 1990;  20 Orsted, 1989).  Table 2 outlines the various products currently used in the  care of RISR and their mode of action based on the literature. Although these interventions are frequently used, no studies have been done to evaluate their clinical effectiveness in the care of RISR with the exception of hydrocolloid dressings and MVPD (Margolin et al, 1990; Shell et al, 1986). Margolin et al (1990) conducted a non-comparative study evaluating healing time, lesion temperature, bacterial growth, and level of discomfort at the lesion site in 20 patients with open skin lesions secondary to RT. Results of this study indicated that the healing process, as measured by number of days until complete reepithelialization, was faster with hydrocolloid dressings (13 days) compared to previously reported information on hydrous lanolin gauze dressing (24 days). Results of this study suggested that a moist clean healing environment that controls exudate was more effective in promoting the healing process than one which only provides a moist healing environment. Moisture Vagour Permeable Dressing The availability of MVPD has offered the possibility of a new approach in the care of open skin lesions secondary to RT. MVPD are thin clear films of polyurethane covered with a hypoallergenic adhesive on one side. These film dressings are permeable to oxygen and water vapours, and impermeable to liquid and bacteria (Barnett, et al, 1985).  They can be removed without  producing undue tissue damage and discomfort (Shell, et al, 1 986). MVPD are applied directly to a clean open skin lesion.  They can be used at the first  21 indication of epidermal erosion and to the point where complete dermal exposure is present. Table 2 Products Used in the Care of Radiation Induced Skin Reactions. PRODUCTS  MODE OF ACTION  Category: RISR With Intact Skin Talcum Powder Corn Starch Hydrocortisone Cream Lubriderm Vitamin A & D Cream  .control pruritus .control pruritus .control pruritus & decrease inflammation .provide moisture .provide moisture  Category: RISR With Open Skin Lesion Wet Compresses -Saline -Astringents -Antibacterial Agents MVPD Gentian Violet Burrows Solutions Silver Sulphadiazine Cream  Hydrocolloid Dressings Hydrogels  cIeanse area .control infection .control infection .provide clean moist environment .dry exudate and control infection .cleanse & debride .provide moist environment and control infection. .provide clean moist environment and control exudate .control exudate  22  The goal of action of MVPD is to provide a moist, permeable, clean environment favourable to the normal healing process (McGowan, 1989). Various studies have been conducted to investigate MVPD in the promotion of healing, control of bacterial proliferation, and reduction of pain. Winter  (1962)  demonstrated in animals that the application of  polyurethane films keeps lesions moist, thereby creating an environment that promotes cell movement and enhances lesion repair. These results were also observed in human lesions by Hinman and Mailback (1963). The evaluation of MVPD in various types of lesions, such as graft donor sites, surgical incisions and superficial pressure sores also suggested that the dressings decrease the healing time of a lesion (Barnett, et al, 1983; Moshakis, et al, 1984). James and Watson (1975), conducted a comparative study involving 53 patients with split graft donor site lesions. All of the patients received the MVPD skin care treatment and the healing rate and discomfort levels were compared to the authors’ previous data about skin care methods. However, no conclusions regarding the healing rate were made because of the great variation among the patients in terms of the thickness of the graft donor site and the procedures used for obtaining the grafts.  The results validated that MVPD  promotes ease of movement at the lesion site without inducing discomfort or tenderness.  Staff reported that MVPD were easy to apply but identified  exudate leakage around the dressings as a disadvantage.  23 Barnett, Berkowitz, Mills and Vistness (1983) did a randomized study on 60 graft donor sites in 25 patients comparing MVPD to a fine mesh gauze dressing with. respect to healing time, pain at the lesion site, occurrence of infection and adhesion of the dressing. Results indicated that patients using MVPD experienced minimal pain  compared to patients using the gauze  dressing. However, the specific criteria used to evaluate pain were not described.  The  mean  healing  time,  reepithelialization, was of 6.8 days (S.D.  =  reported  in  days  to  complete  2.0 days) for the MVPD group and  of 10.5 days (S.D.= 5.5 days) for the gauze dressing group. The authors reported that there was a much faster healing rate associated with the MVPD than with the fine mesh gauze dressings but the statistical test used to assess significance was not mentioned.  Due to a problem in the criteria used to  evaluate the dressings adhesion, this outcome was not reported in the final results. Although the patients’ ages ranged between 8 months and 80 years , the authors did 2 and the size of the donor site dressings between 8 to 800 cm not make reference to how these variables affected the results obtained. Moshakis, Fordyce, Griffiths, McKinna (1 984) conducted a randomized comparative study using MVPD and gauze dressings in patients who had undergone breast surgery. A total of 120 patients took part in the study, 61 patients were included in the MVPD group and 59 in the gauze dressing group. The study used linear scales to measure serous exudate, erythema, tenderness, and scab formation.  The scales and criteria used for evaluation were not  24 described. This study evaluated both the patients’ and the nurses’ perceptions. Patients using the MVPD reported a higher degree of satisfaction with their dressings than patients using gauze dressings. Nursing staff stated that MVPD were easy to apply but once again reported that leakage around the dressing was a problem. Shell et al, (1986) conducted a randomized pilot study comparing MVPD and lanolin gauze dressings in terms of their capacity to promote healing and ensure comfort in patients with open skin lesions secondary to RT. Sixteen patients were included in the study.  Eight were randomized to receive the  MVPD and eight to receive the lanolin dressing. Healing time was measured in days from lesion onset to the complete reepithelialization of the lesion. The average healing time was 19 days for MVPD and 24 days for the lanolin gauze. The results were not statistically significant due to the small sample size. Shell attempted to explore the concept of discomfort but found it difficult to quantify due to the changing nature of the lesions. Overall, the results of this study were similar to previous studies and documented that MVPD can be used during RT without creating an undesirable dispersement of radiation to the skin, referred to as a bolus effect. Gentian Violet Gentian Violet, (methylrosaniline chloride 1 %), is one of the current products used in British Columbia,to treat open skin lesions secondary to RT. GV is applied directly, or spread on a gauze and then applied to the irradiated  25 area.  GV acts as a topical antifungal and antibacterial agent (Berner &  Rotenberg, 1990).  It has been utilized for years for open skin lesions  secondary to RT (British Columbia Cancer Agency, 1 992; Hassey et al, 1982; Ratliff, 1 990; Schwade & Lichter, 1 982; Thomson, 1 980). The mechanism of action for GV relates directly to properties of the skin. Skin has a normal microbial flora which includes bacteria and fungi.  The  constant shedding of the corneum of the skin creates a dry unfavourable habitat which prevents invasion of these pathogenic organisms (Wood & Blada,1 985). The application of GV on the injured epidermis maintains this dry habitat, and thereby inhibits bacterial and fungal invasion (Springhouse, 1991). No studies evaluating the pharmacological properties of GV in relationship to RISR have been completed to date.  A study including 19 patients who  developed an open skin lesion following RT for early breast cancer is currently being conducted by Dr. D. Pickering (personal communication, June 24, 1993) at Pembery Hospital in Kent, England. The study uses a comparative design involving GV and a hydrogel dressing called “2nd Skin”-J-M. The study evaluates the effectiveness of the two treatments in relation to the level of discomfort and irritation of the skin at the lesion site, as well as restriction of arm movements and sleep disturbances.  The details of the study methods,  measurement tools, and the final results are not available. The preliminary findings, however, appear to show that healing time is reduced and that patients express a higher degree of satisfaction with the moist method of  26 promoting healing. Summary of the Literature Review Although skin reactions secondary to RT occur less frequently since the introduction of megavoltage RT equipment they still are identified by patients receiving a high dose of radiation (> 4,000 cGy) as a major side effect to RT. A review of the relevant literature revealed a broad spectrum of care techniques for RISR, but very few are based on systematic evaluations of their effectiveness. Two products currently used in the care of open skin lesions secondary to RT are; GV and MVPD.  No studies to date were found that  evaluated the effectiveness of GV in the treatment of any form of tissue lost injuries including RISR. Studies were found that evaluated the use of MVPD in tissue lost injuries including RISR.  Caution must be used in drawing any  definite conclusion regarding the few studies that have been done to date. Most of the studies to date used non-comparative designs, had crude methods to assess the study outcomes, and did not control for important factors such as the size of the lesion and patient’s age. Shell’s et al, (1986) pilot study undertook the scientific evaluation of MVPD in the care of open skin lesions secondary to RT, but because of the small sample size, no clear conclusion could be drawn. Further studies are needed to evaluate the effectiveness of the various treatments used in the care of RISR, particularly the treatments of GV and MVPD.  27  CHAPTER 3 Methods Introduction In this chapter the research design, sample selection criteria, procedures used for data collection and data analysis as well as the means used for the protection of human rights will be described. Research Design This study used an experimental, randomized controlled design (Figure II). All patients who met the selection criteria and agreed to participate in the study were randomly assigned, using a table of random numbers, to receive either GV or MVPD skin care protocol (Appendices C & D).  The indicators used to  measure the study outcomes included: the number and size of the open skin lesions; characteristics and size of erythema; amount and characteristics of exudate; grade of healing; and the level of discomfort at the lesion site. The study ended when the lesion healed. All of the observations and procedures were carried out by the investigator. Selection Criteria Patients were included in the study provided they met the following criteria: 1.  Aged between 18 and 70 years.  2.  Diagnosed with head and neck cancer.  28 Figure II. Design of the Study  O  1 Op E 1  2 Op  3 Op  1 Op  2 Op  3 Op  Qpfl  /  R  Op  Legend: Identification of potential participants.  =  QX  R  Occurrence of an open skin lesion. Personal and medical histories as well as baseline assessments of the following study outcomes are performed: (1) size of the open lesions; (2) size and characteristics of the erythema;(3) amount and characteristics of the exudate; (4) cultures and photographs; (5) grade of healing; and (6) level of discomfort at the lesion site.  =  Random assignment to one of the study groups.  =  1 E  =  Experimental group, MVPD.  2 E  =  Control group, GV.  1 to Op Op  Op  =  =  Assessment of the skin condition (number 1 ,2,3,5 above) and level of discomfort are done 2 to 3 times per week. Cultures and photographs of the lesion are taken approximately every seven days. Lesion healed, end of study.  29 3.  Scheduled to receive a total dose of 4,000 cGy or greater of external radiation fractionized daily.  4.  Had developed an open skin lesion secondary to RT within the past 24 hours.  5.  Were able to understand and answer questions in English.  6.  Were able to follow the study protocol.  7.  Lived within the Greater Vancouver Region.  Patients were excluded from the study if they had any of the following: 1.  A history of skin disease within the treatment field area.  2.  An open lesion at the start of RT.  3.  Clinical and microbiological signs of an  acute  infection in a lesion in the treatment field area. 4.  A known skin allergy to GV or MVPD.  5.  Received previous RT to the treatment field area.  6.  Received or currently receiving chemotherapy. Instruments for Data Collection  Two forms, the Personal and Medical Histories form (Appendix E) and the Assessment Flow Sheet (Appendix B), were designed for the study based on the literature and other instruments used to record to the skin response to radiation and the healing process (Bloomer & Hellman, 1975; Cunon, 1985; Malkinson & Keane, 1 981; Overgaard et aI, 1987; Sitton, 1992; Wang, 1991;  30 Yasko, 1983). The Personal and Medical History Form was used to record: (1) basic demographic data (age, gender, language, and place of residence); (2) medical history (history of RT or surgery in the RT field, current medications, history of diabetes, peripheral vascular disease, allergies, skin cancer or acne); (3) radiation therapy plan parameters (RT site and field size, dose received, number of fractions) and (4) skin care routine. The Assessment Flow Sheet was used to document: (1) size and number of lesions; (2) size and characteristics of the erythema; (3) amount and characteristics of the exudate; (4) grade of healing; (5) the level of discomfort at the lesion site; and (6) side effects associated with the study treatments. The size of each lesion was measured using a flexible grid designed by Smith and Nephew (Appendix A). The grid was placed on top of the lesion and the edges of the lesion were traced with a marker pen.  The surface was  2 by counting the number of squares within the traced area and calculated in cm then adding these scores together to form one score. The grade of healing of the lesion was determined by matching the amount of reepithelialization present in  each lesion to the following  classification: Grade 1, none; Grade 2, spotty small areas; Grade 3, centrally larger areas; Grade 4, complete healing (Appendix F) (Cunon, 1985).  This  classification is based on the fact that healing is a gradual process that can be evaluated by observing the amount of reepithelialization; reepithelialization  31 being defined as the replacement of lost tissue with tissue of the same or similar type. This process ends with the complete healing of the lesion. The size of the erythema was determined using the same procedure described for the measurement of the lesion size. The characteristics of the erythema were assessed by matching the colour of the skin to the colour groupings presented in Appendix G.  In the literature the characteristics of  erythema are usually described as faint, bright or deep hues of red with no other further clarification (Malkinson & Keane, 1 981). To improve the accuracy of the evaluation, specific colour groupings were developed for this study and were validated with BCCA professional staff prior to their use by asking them if they agreed with the colour grouping selected for this study to describe erythema  .  If the erythema reflected more than one colour grouping then the  colour grouping that occupied more than 50% of the total area was selected. Part of this study was to measure and evaluate the amount of exudate from the lesions by tracing for the MVPD group, the pockets of fluid accumulated under the dressing and for the GV group, the amount of crusting present, using the same procedure previously described for the determination of the lesion size.  However, it was not possible to make an accurate  measurement using this method for the following reasons: (1) the exudate did not accumulate under the MVPD to form pockets in all patients; (2) a large amount of leakage occurred around the MVPD in two of the patients; and (3) the crusting in the GV group represented an accumulation of the exudate from  32 one assessment visit to the next as well as the total accumulated exudate from the beginning of the lesion onset. Therefore, this outcome indicator was not assessed in this study. The characteristics of the exudate were evaluated according to the following scale; (0) none; (1) serous; (2) serous sanguineous; (3) sanguineous; (4) purulent (Appendix H). Discomfort was defined as the level of burning, itchiness, pulling, and/or tenderness experienced by patients at the lesion site. These components were chosen based on various studies describing the patient’s experience with RT (Barnet et al, 1 983; Bloomer & Hellman, 1975; James & Watcon, 1 975; King et al, 1985; Malkinson & Keane, 1981; Pickering, 1993; Shell et al, 1986; Sitton, 1992; Wang, 1991).  Each component of discomfort was assessed  using a visual analog scale (VAS). The VAS is easy to administer and score (Jeasen, Karoly & Brauer, 1986) and has been shown to be reliable and sensitive to pain intensity variations (McCaffery, 1989; Seymour, 1982). The VAS used in this study consisted of a 10 cm single horizontal line with the anchor words of none and excruciating at each end. Patients used a moveable marker to indicate a point on the line which best reflected their level of discomfort. A score was obtained by measuring in cm the distance from the first anchor word to the mark.  33 Pre-test All the instruments and procedures used in this study were pre-tested on 5 patients with head and neck cancer for one to two day period during the initial formation of a lesion. During this time period the problems identified in relationship to measuring the amount of exudate was not apparent due to the brief time frame selected for the pre-testing period. Lesions during the time period had either scant or no exudate present. The pre-testing did indicate that the VAS was easily understood by patients and the components selected to describe discomfort clearly reflected the quality of the patient’s pain experience. No revisions were necessary. Procedures Patients included in this study were recruited from the Radiation Therapy Department at the British Columbia Cancer Agency, Vancouver Clinic.  All  patients had either completed or were near completion of a 4 to 5 week RT treatment plan. The Radiation Oncologists responsible for the primary medical care identified potential study participants and obtained their permission to be approached by the investigator. If patients were interested in taking part in the study, a meeting took place to explain the study and obtain their consent (Appendix I). Initially, a baseline assessment was done that included the collection of personal and medical history information. When an open lesion first appeared, the following data were collected; number and size of the lesions, size and  34 characteristics of the erythema, amount and characteristics of the exudate, grade of healing, and level of discomfort at the lesion site. These parameters were assessed two to three times per week until the lesions healed. Baseline cultures were performed to determine that the lesion was free of an acute infection prior to starting the study.  Cultures of the lesions were repeated  every seven days until the lesion healed.  These were done following the  procedure outlined in Appendix J and microbiological evaluations were performed by the microbiology department at BCCA, Vancouver Clinic. The results were reported to the primary physician and the investigator. If purulent exudate was observed, additional cultures were taken. After the baseline data was collected patients were randomized to either the GV or the MVPD skin care treatment groups and were oriented to the skin care protocols (Appendices C & D). The investigator performed the skin care procedures initially and at each subsequent visit and the patient or care provider did it at other times. The MVPD (Op-Site), GV and sterile dressings supplies were provided free of charge by Smith and Nephew and BCCA. Patients were seen at least 2 to 3 times a week either in the BCCA Vancouver Clinic’s Radiation Day Care or at their home to evaluate the study outcomes and assess the difficulties or problems the patients had with the study treatments. The frequency of the visits varied depending on the need for assistance and/or for dressing changes and patient’s availability to come to the clinic.  35 Photographs of the lesion were taken at the time of lesion onset and repeated every seven days until the lesions healed to provide a pictorial record of the lesion status throughout the study. These photographs of the lesions were done by the investigator following the procedure outlined in Appendix K. Due to a technical problem with the camera equipment the quality of the photographs were not adequate for evaluation and therefore will not be included in this thesis. Data Analysis Procedures Data from the coded Personal and Medical History Forms and the Assessment Flow Sheets were computerized using the Statistical Program for the Social Sciences (SPSSX). General characteristics of the sample in terms of (1) soclo-demographics (age, gender, language, place of residence); (2) RT treatment plan parameters (treatment site and field size, dose received, number of fractions); (3) skin condition (size and characteristics of the erythema, number and size of the lesions [the size of the lesion was always reported as the total area of all of a patient’s lesions], characteristics of the exudate and grade of healing); and (4) level of discomfort were described using basic descriptive statistics (frequency, range, mean). Prior to testing the hypotheses, the equivalence of the study groups at the onset of the lesion was assessed.  Equivalence was determined by  comparing age, RT treatment plan parameters, skin condition and level of discomfort, using the Mann-Whitney U-test. The level of significance was set  36 at.p  =  0.05 (Conover, 1980; Pagano, 1981). The first hypothesis related to the rate of healing was assessed by  testing the differences between the two study groups in terms of: (1) the number of days from lesion onset to complete healing to evaluate the overall healing rate; (2) the number of days from maximum lesion size to complete healing to verify the effectiveness of the study treatments when the largest amount of tissue damage was present and (3) the number of days from grade 1 to 2; grade 2 to 3; and from grade 3 to 4 to assess the impact of the study treatments on the various phases of the healing process. The second hypothesis related to the level of discomfort experienced by patients at the lesion site was tested by looking at the differences between the study groups for each of the components of discomfort (burning, itchiness, pulling and tenderness) at two points; 24 hours after beginning the study treatment and when the lesion was at its maximum size. The latter evaluation was chosen based on the assumption that a larger lesion would produce more discomfort than a smaller lesion. All testings were performed using the Mann Whitney U-test, with a level of significance set at  0.05.  AssumDtions The following assumptions guided the study: 1.  Patient’s  receiving  RT for their  cancer are  interested  in  participating in the study. 2.  Patients are able to follow the skin care protocols adequately once  37 they have been taught. 3.  A larger lesion will produce more discomfort than a smaller lesion. Limitations The following limitations were identified in the study:  1.  The  small  convenience  sample  of  patients  restricts  the  generalization of the results beyond the scope of the study. 2.  Instruments used to measure the outcomes (grade of healing, characteristics of erythema and the characteristics of the exudate) have not been fully assessed for reliability and validity. Procedure for the Protection of Human Rights This proposal was approved by the Clinical Ethics Committee of the  University of British Columbia, the BCCA Nursing Division Research Committee and the Radiation Oncologists who provided care to the head and neck cancer patients. Patients were informed of the purpose and procedures of the study as well as the benefits and inconveniences that may occur during the study. Patients were informed that their participation was voluntary and their refusal or withdrawal from the study would not affect in any way their treatment or care at the BCCA. Patients signed a consent form, following full disclosure of the study. The original consent form remained with the patient’s chart and a copy was given to the patient. Patient’s names were never used and confidentiality was maintained by using a code number on all documents.  38 The procedures used in this study are acceptable skin care treatments for RISR in cancer centres. To ensure their protection, patients were removed from the study when side effects to the study treatments such as an allergic reactions or infection occurred. Summary of the Methods This chapter has presented the methods used in this study: the design; sample selection criteria; procedures for data collection and data analysis; and the measures used to protect the patient’s rights.  39 CHAPTER 4 Presentation and Discussion of the Results Introduction This chapter consists of three sections. The first section presents the characteristics of the sample and the equivalence of the study groups in relation to:  (1)  socio-demographic characteristics; (2)  medical history and RT  parameters; (3) skin condition; and (4) discomfort level at the lesion site. The second section reports the findings related to the two hypotheses. Finally, the last section discusses the results of the study. General Characteristics of the SamDle Thirteen patients were enroled in this study. Of these, 6 patients were assigned to the MVPD group and 7 to the GV group. Four patients did not complete the study (1 in the MVPD group and 3 in the GV group) for the following reasons: allergic reaction to the adhesive product used in the MVPD (#10); severe burning (#11,  #12) related to the GV treatment; and  inconvenience of GV (#13) which was found to be too messy. All 4 patients withdrew from the study within 48 hours and therefore will not be included in the analysis. Socio-demoqraphic Characteristics Five patients had English as their primary language, 3 had Cantonese and 1 had Mandarin. Seven men and 2 women aged 41 to 70 years (Mean (M) 56.7) participated in the study (Table 3).  =  The mean age was 59.8 (Range:  40 51 to 64 years) and 53.6 years (Range: 41 to 70 years) for the GV group and MVPD group respectively.  There was no significant difference  between the two groups in terms of age. Medical and Radiation Therapy Characteristics Medical and RT data to be reported included: (1) tumour site, history of head and neck surgery, RT, chemotherapy and other medical conditions; and (2) size of the RT field, total dose of radiation received, number of fractions, duration of RT and number of breaks in the RT schedule (Table 3). Patients included in this study had various types of head and neck malignancies, most often cancers of the nasopharynx and of the tongue (Table 3). None of the patients had received radiation or chemotherapy prior to study or had a history of skin cancer, allergies or acne. Three patients, 2 in the GV group and 1 in the MVPD group, reported having other medical conditions including diabetes (#6), peripheral vascular disease (#6,#2,#8) and one had previous head and neck surgery (#6). Overall the RT lasted, on average, 38.7 days (Range: 34 to 43 days), 38 days and 39.6 days for the GV and MVPD groups, respectively.  Patients  received during that period an average total dose of RT of 5,595 cGy (Range: 4,000 to 6,000 cGy) (Table 3), with a mean of 5,626 cGy for the GV group (Range: 4,500 to 6,000) and of 5,377 cGy for the MVPD group (Range: 4,000 2 (Range: 60.5 cm2 to 780 to 6,000). The average RT field size was 400.4 cm ) and of 2 , with a mean of 303.1 for the GV group (Range: 120 to 420 cm cm ) 2  M M M M M M M  Gender  70 44 53 60 41 72 56.7 53.6 56.1 56.7  64 51 62 62 45 43 62 55.6 59.8  Age  a,  ,  patients who completed study, diabetes; b, peripheral vascular disease, 5 Q=O.O  Total M Total M*  M  MVPD Group M 1* 4* M 5* F M 9* F M 10  11 12 13 M  7*  3*  GV Groun  Patient  Vocal Cord Nasopharynx Nasopharynx Pharynx Tongue Pyriform Sinus  Vocal Cord Nasopharynx Submandibular Pyriform Sinus Tongue Tongue Nasopharynx  Tumour Site  6,000 4,500 4,000 6,000 5,760 6,000 5,377 5,252 5,439 5,438  6,000 4,500 6,000 6,000 6,000 6,000 4,500 5,571 5,626  Dose  25 20 20 25 24 25 23.1 22.8 23.4 23.2  25 20 25 25 25 25 20 23.8 23.6 36 47 45 34 36 36 39 39.6 38.7 38.8  36 43 36 37 36 38 43 38.4 38.0  Radiation Therapy Fractions Duration  Table 3 Demociranhic. Radiation TheraDv and Medical Characteristics of the SamDle  61.0 780.0 303.5 336.0 538.0 276.0 382.4 403.7 400.4 353.4  120.0 392.5 420.0 280.0 562.0 584.0 420.0 396.9 303.1  H  2 Field Size cm  42 2 for the MVPD group (Range: 61 to 780 cm 403.7 cm ) (Table 3). The 2 number of RT fractions ranged from 20 to 25,  (M  =  23.6), with the  mean of 23.6 for the GV group and 23.1 for the MVPD group.  Four  patients, 2 in the GV group and 2 in the MVPD group, had their RT interrupted for 7 consecutive days because of scheduling difficulties. No interruptions were related to adverse reactions to the RT. There were no significant differences between the two groups in relationship to any of the above RT parameters. In terms of skin care to the area, all patients used only tap water to cleanse the skin within the therapy field area.  Cornstarch and  hydrocortisone cream 1 % were used to control itchiness prior to the development of lesions in 4 patients, 2 in the GV group and 2 in the MVPD group, but all had stopped the use of these products prior to entering the study. One patient was using cologne daily, but stopped prior to the start of RT. Skin Condition at Lesion Onset and at Maximum Lesion Size The equivalence of the study groups at the beginning of the study is presented in terms of date of occurrence of the lesion in relation to RT, number and size of lesions, size and characteristics of erythema, characteristics of exudate, microbiological results, grade of healing and level of discomfort at the lesion site. The lesions first occurred between 40 and 47 days  (M  =  44.9  43 days) after beginning RT. Two of the 9 patients developed their lesions prior to completing RT and 7 after their RT ended. At the time of lesion onset, patients had, on average, 2.5 lesions (range of 2 to 4) which 2 (Range: 1.5 to 46 cm comprised a total surface area of 20.1 cm )(Table 2 4). A deep purple erythema was observed in 55% of the patients and the remaining had a bright erythema. The mean size of the erythema 2 (Range: 45 to 384 cm was 200 cm ). The majority of lesions (n =6) 2 had serous-sanguineous exudate, 2 had serous exudate, one had no exudate and all were free of microbiological infections.  None of the  lesions showed evidence of reepithelialization. The lesions reached their maximum size 44.9 days after the beginning of RT. On average, patients had 2 lesions with a mean size 2 (Range: 1.5 to 408 cm of 160.5 cm ). A deep purple erythema was 2 observed in 67% of patients and the remaining had a bright erythema . All 2 (Table 5). The size of the erythema was at this time 201.3 cm lesions except one (#8) had serous-sanguineous exudate and none had evidence of microbiological infection. Discomfort Level at Lesion Onset Levels of discomfort varied from 2 to 9 for burning from 0 to 10 for itchiness  (M  =  5.8); from 5 to 8 for pulling  and from 3 to 10 for tenderness  (M= 6.7) (Table 6).  (M (M  =  5.8);  =  6.3);  41 41.5  3.3 2.7  44.9 44.9  160.5 121.5 18.3 20.1 1.7 1.8  b,  166.0  19.3  001.5 408.0 243.0 077.0 035.0 154.9  088.0 23.1  01.5 12.3 14.0 23.0 35.0 17.2  056.0 152.0 400.0 056.0  19.0 04.4 07.6 46.0  Size (cm ) 2 at Maximum Size at Onset  1 1 2 2 3 1.8  diabetes peripheral vascular disease 12=0.05 Note. Size of lesion is the sum of the areas of all of the patient’s lesions.  a  Mwithout#6  M  MVPD Group 46 1 41 4 47 5 b 8 43 38 9 43 M 1 1 2 2 3 2.7  M  46 47 49 44 38 44.8  3.8  45  39  Mwithout#6  1.5  1.7  2.7  45  40  7  3  1 2 1 2  2 4 3 2  # of Lesions at Onset at Maximum Size  42 50 45 43  Days From Beginning RT at Maximum Size at Onset  39 39 36 42  GV Group  Patient  Table 4 Skin Lesions Characteristics at Onset and Maximum Lesion Size  DP DP DP BR  Colour  210.6  045.0 180.0 200.0 060.0 180.0 164.2  200.0 384.0 360.0 124.0 256.9*  Size  Erythema at Onset  diabetic bperipheral vascular disease BR, bright erythema DP, deep purple erythema SR, serous exudate SS, serous-sanguineous exudate * =0.05  a,  TotaiM  M  MVPD Group BR 1 DP 4 DP 5 b 8 BR BR 9  M  7  a,b 6  3  b 2  GV Group  Patient  BR DP DP BR BR  DP DP DP DP  Colour  121.3  045.0 408.0 200.0 060.0 180.0 178.6  200.0 152.0 420.0 124.0 224.0  Size  at Maximum Size  SS NONE SS SR SS  SS SS SS SR  SS SS SS SR SS  SS SS SS SS  Exudate at Maximum Size at Onset  Table 5 Ervthema and Exudate Characteristics at Lesion Onset and Maximum Lesion Size  01  3.8  3.3  6.8  6.3  5.8  5.8  b,  diabetic peripheral vascular disease Note. B, burning (0 to 10) I, itchiness (0 to 10) P. pulling (0 to 10) T, tenderness (0 to 10) * R < 0.001  a,  Total  M  2 5 0 0 0 1.4*  2 5 0 0 0 1.4*  3 6 7 M  3 3 8 7 10 6.2  3 10 4 6 5.8  3.9  5.7  3.2  8 6 6 7 6.8  0 2 0 0 2 0.8* 4.2  3.2  8 7 9 6 7.5  2 2 0 0 0 0.8*  3 8 5 6 5.5  4.6  0 2 0 4 5 2.2*  6 8 8 6 7.0  Maximum Lesion Size I P B T  0 2 2 2 2 0.8*  6 10 8 6 7.5  T  0 0 2 5 0 5 0 4 2 5 0.8* 3.8*  8 7 9 6 7.5  24 Hours I P  5 8 6 7 8 6.8  3 10 4 6 5.8  B  5 9 0 7 8 5.8  5 10 9 5 7.3  T  MVPD Group 5 1 5 4 5 5 b 8 8 9 9 6.4 M  5 7 5 6 5.8  Onset I P  3 10 4 6 5.8  B  8 8 2 3 5.3  b 2  GV Group  Patient  Table 6 Level of Discomfort at Three Time Periods  47 Equivalence of the Grours There were no significant differences between the two study groups in terms of: (1) lesion onset in relation to the beginning of RT (GV group:  M= 45 days; MVPD group: M= 43 days); (2) size of the lesion  at onset (GV group:  M  19.3 cm ; MVPD group: 2  the lesion at maximum size (GV group: =  ); (3) 2 M 17.2 cm  ; MVPD group: M 2 M= 166.0 cm  1 52.9 cm ); (4) size of erythema at maximum lesion size (GV group: 2  M  =  ; MVPD group: 2 224 cm  ); and (5) level of 2 M= 178.6 cm  discomfort at the lesion site at the beginning of the study (Table 6). In conclusion, the two study groups were equivalent in relation to the above parameters with the exception of the size of erythema at lesion onset (GV group:  2 and , Range: 124 to 384 cm 2 M= 267 cm  . The GV group had cm ) , Range: 45 to 200 2 2 MVPD group: M= 133 cm a significantly larger area than did the MVPD group (jj  9,  =  0.05),  but this difference was not seen when the lesions were at their maximum lesion size. Hypothesis One Regarding Rate of Healing The first hypothesis tested was that open skin lesions secondary to radiation treated with MVPD will heal faster than lesions treated with GV.  The 4 patients who did not complete the study were excluded  from the analysis. Also, because the healing process may have been affected by factors such as diabetes and surgery, analysis was done  48 excluding patient #6 who had both of these conditions. The number of days from lesion onset to complete healing varied from 5 to 46 days to 46 days  (M  =  (M= 18.5). Healing time for the GV group, was 1 5  25) and for the MVPD group 5 to 26 days  (M  =  12).  There was a significant difference between the two groups. The lesions treated with MVPD healed at faster rate than those treated with GV (U 8, p  =  0.05) (Table 7). The MVPD group had healing rates as low  as 5 to 6 days, whereas the lowest rate in the GV group was 1 5 days. When the lesions were at maximum size an overall average of 13.8 days were required for complete healing (Range: 5 to 35). For the GV group, the average was 21 days (Range: 14 to 35) and for the MVPD group it was 6.6 days (Range: 6 to 20) (Table 7). There was a significant difference between the two groups  (  =  8,  =  0.05) (Table  7). There were differences between the two groups during phases of the healing process, that is moving from one grade level to the next. The means for the GV group were: grade 1 to 2, 3.3 days; grade 2 to 3, 8.7 days; and grade 3 to 4, 13.3 days. Whereas, the mean scores for the MVPD group were: grade 1 to 2, 3.8 days; grade 2 to 3, 3.4 days;  49 Table 7 Healing Rates From Lesion Onset and Maximum Lesion Size to ComQlete Healing Patient  From Onset  From Maximum Size  GV Groun 15.0 46.0 80.0 15.0  14.0 35.0 71.0 14.0  39.0 25.0  33.5 21.0  9  06.0 26.0 13.0 10.0 05.0  06.0 20.0 11.0 09.0 05.0  M  12.0*  06.6*  Total M  25.5  20.1  18.5  13.8  3 6’ 7 M  M  without # 6  MVPD Group 1 4 5 b 8  Total a b, *  M without # 6  diabetes peripheral vascular disease R = 0.05  and grade 3 to 4, 5.6 days. The differences were statistically significant from grade 2 to 3 (spotty sparse areas of reepithelialization to central larger areas of reepithelialization) (  =  8,  =  0.05) (Table 8).  Hypothesis Two Related to Discomfort Levels at the 0en Lesion Site The second hypothesis tested was that patients using MVPD will  50 experience less discomfort at the lesion site than patients receiving GV. On the day the lesions occurred, the mean VAS scores for both groups were above the scale midpoint for each of the sensations (burning 5.8; itchiness  M=  M= 5.8; pulling M= 6.3 and tenderness M= 67) (Table  6). Patients, on the MVPD treatment had their level of burning decreased from a mean of 6.4 to of 1 .4 after receiving the treatment for 24 hours. A further decrease was also noted when the lesions were at maximum size  (M  =  0.8).  On the other hand, patients on the GV  experienced burning sensations which increased when the lesions were at maximum size  (M= 5.3 at lesion onset, M  =  5.8 after 24 hours and  M= 6.8 at maximum lesion) (Table 6 and Figure IV). Itchiness decreased from a mean of 5.8 to 1 .4 after being on the MVPD for 24 hours and a further decrease was seen when the lesions were at maximum size (M  =  0.8). Itchiness levels remained constant for  the patients that received the GV treatment 24 hours after beginning the treatment and  (M  =  5.8 at onset,  M= 5.8  M= 5.5 at maximum lesion)  (Table 6 and Figure V). Pulling decreased from a mean of 6.8 to of 1 .8 after 24 hours on MVPD and as was the case for, the other sensations, further decrease was seen when the lesion was at maximum size  (M  =  0.8).  Pulling  levels were increased after the patients received the GV treatment and  51 remained the same when the lesions were at their maximum size (M 5.8 at lesion onset,  M= 8.0 24 hours after beginning the treatment and  M 7.5 at lesion maximum) (Table 6 and Figure VI). Table 8 Duration of Healing in Days in Terms of Grade of Healing  Grade lto2  Grade 2to3  Grade 3to4  7  4 4 12 2  8 10 19 8  3 32 49 5  M Mwithout#6  5.5 3.3  11.3 8.7  22.3 13.3  MVPD 1 4 5 8” 9  2 9 4 2 2  2 7 6 1 1  2 10 4 8 4  M  3.8  34*  5.6  M  4.7 3.6  7.4 6.1  14.0 9.5  Patient  GV b 2  3 a,b 6  Mwithout#6 a  diabetes peripheral vascular disease * 0.05 Note. Grade 1: no healing or reepithelialization. Grade 2: spotty areas of healing, or reepithelialization. Grade 3: healing present centrally, larger areas of reepithelialization. Grade 4: complete healing or complete reepithelialization.  b,  —  =  52  Figure III. Level of burning at lesion onset, 24 hours on study and when lesion was at maximum size.  7  6.75  6 5 to 4 3 0  2  ci) ci)  I  0  Note. 0 to 10, none to excruciating  • Lesion Onset •24 hours on study •When Lesion At Maximum Size  53  Finally, the levels of tenderness were also reduced with the MVPD treatment but not as much for tenderness as for the other sensations  (M= 6.2 to a M  =  3.8 24 hours after beginning the treatment and  M=  2.2, lesion at maximum). Patients on the GV treatment, on the other hand, did not experience any improvement in their level of tenderness (M =  7.3 at lesion onset,  M= 7.5 24 hours beginning the treatment and  M= 7.0 at lesion maximum) (Table 6 and Figure VII). There were significant differences between the two groups at 24 hours after beginning the treatment and when the lesions were at their maximum size for each discomfort sensation (U  =  8, R < 0.001) (Table  6). Besides the allergy to the adhesive product used in the MVPD and the severe burning already mentioned in the section entitled “General Characteristics of the Sample”, no other side effects to the study treatments were noted. Discussion In this section, the findings of this study will be discussed in relation to the theoretical framework and the literature as well as the main methodological procedures.  54  Figure IV.  Level of itchiness at lesion onset, 24 hours on study and  when lesion was at maximum size.  •Lesion Onset •24 hours on Study • When Lesion at Maximum Size  Cl) C,)  0 C-)  4) C  0 -i  11)  Total Sample  Gentian MVPD Group Violet Group  0  Note. 0 to 10, none to excruciating  55  Figure V. Level of pulling at lesion onset, 24 hours on study and when lesion was at maximum size.  8 8 7 6 5 •r-1  •Onset of Lesion •24 hours on Study •When Lesion at Maximum Size  z 0  G)  n  Total Sample  Gentian Violet Group  MVPD Group  Note. 0 to 10, none to excruciating  56  Figure VI. Level of tenderness at lesion onset, 24 hours on study and when lesion was at maximum size.  8 7 6 Cl)  G)  5  ci) V ci) E-  4  0  • Onset of Lesion •24 hours on Study •When Lesion at Maximum Size  3 2  ci) ci)  I  Total Sample  MVPD Group Gentian Violet Group  Note. 0 to 10, none to excruciating  57 Findings Related to the Hypotheses First Hypothesis The results of this study confirm that: (1) the open skin lesions treated with MVPD healed significantly faster than lesions treated with GV as indicated by the healing rates from lesion onset to complete healing and from maximum lesion size to complete healing; (2) the healing rate of lesions treated with MVPD was faster once the process of reepithelialization had been initiated and significantly faster between grade 2 and 3. The findings in this study are consistent with those reported in other studies evaluating the use of moist healing methods in the care of open skin lesions secondary to RT (Dini et al, 1 993; Margolin et al, 1990; Shell et al, 1 986). Furthermore, they strongly suggest that MVPD has properties that facilitate the healing process. Radiation damages the DNA structure of the cells of the skin (Bloomer & Hellman, 1975). formation  of  an  open  skin  This cell damage can results in the lesion.  Once a  lesion  is  formed  reepithelialization of the tissue takes place primarily by cell movement; the cells migrate across the lesion until it is completely closed (Winters, 1 965). The healing process can be enhanced by various means such as protecting the lesions against contamination, friction or trauma, maintaining a clean moist environment and ensuring adequate oxygen,  58 nutrition and fluid levels. MVPD provides a clean moist protective barrier that facilitates cell migration. MVPD, also encourages the free passage of oxygen into the lesion which promotes the healing process. In this study, differences were seen between the two groups in relation to the overall healing rates.  In addition the study results  indicated that MVPD is most effective once the reepithelialization process was most active; that is when the lesion moved from grade 2 to grade 3 and from grade 3 to grade 4.  These differences were  statistically significant in relationship to the time it took for the lesion to progress from grade 2 to 3. Second Hypothesis The results of this study confirmed that the level of discomfort was significantly lower in patients treated with MVPD.  It was clearly  evident from these results that the intensity, for all four sensations, changed dramatically in the MVPD group once the treatment was initiated.  Patients receiving the GV treatment did not experience any  improvement in their sensations; discomfort was, in some instances, even enhanced. In fact, 2 patients in GV group with lesions greater than 2 had twice as much discomfort (VAS scores of 5 and 9) than 2 100 cm patients having similar lesions treated with MVPD (VAS scores of 0 and 2). The reasons for the differences probably relates to the properties of MVPD and GV. MVPD creates a moist environment that prevents the  59 skin from puckering around the open lesion site and provides a constant protective barrier to the abraded nerve endings. GV on the other hand, because of its drying properties, increases the puckering around the lesion as well as creating a scab that frequently cracks. The following results, although not directly related to this hypothesis provide valuable clinical information.  For the majority of  patients, the lesions developed after completing their RT. This finding is consistent with the literature describing the effects of RT on the cellular structure and normal physiological processes of the skin. Skin cells on average have a mitotic rate of 14 to 21 days, but this is shortened during the healing process (Dagher, 1985). Radiation affects the mitotic rate by destroying the DNA structure of skin cells (Bloomer & Hellman, 1975; Malkinson & Keane, 1981) and this effect persists for at least 7 to 21 days following RT (Frogge, 1982).  Thus, the skin  damage secondary to RT can occur well beyond the period of active treatment. It was also noted that the dose of radiation received, patients with 2 developed lesions greater a treatment field size greater than 300 cm 2 and patients whose treatment field size was less than 300 than 100 cm . These observations, lead 2 2 developed lesions smaller than 100 cm cm this investigator to think that the size of the treatment field is one of the major factors in the determination of lesion size.  60 Methodological Considerations In this section, the findings of the study are discussed in terms of the representativeness and equivalence of the sample and methods used to evaluate the study outcomes. Representativeness of the Sample Head and neck cancer is 2 or 3 times more prevalent in males than females (Schottenfeld & Fraumeni, 1982; King et al, 1 985; Woodtil & Van Ort, 1 991) and on average affects patients 65 years of age or older. In British Columbia, the usual RT plan for head and neck cancer is the administration of 4,000 cGy to 7,000 cGy of radiation given in 20 to 30 fractions. In this study, 9 patients, 7 males and 2 females, with a mean age was 56.7 yearswere enroled. During the course of their 39 days of RT, they received between 4,000 cGy and 6,000 cGy of radiation, administered on average in 23 fractions. Although the mean age of the study sample was slightly lower than the B.C. provincial statistics (BCCA, 1991), these figures indicate that the study group shared similar demographic characteristics and RT plan parameters with the B.C. head and neck cancer population (BCCA, 1992). Equivalence of the Study Groups The equivalence was assessed by comparing the two study groups in terms of: age; RT plan parameters; skin condition at lesion onset; and  61 level of discomfort at lesion onset.  The GV and MVPD groups were  equivalent in terms of all the above variables except for the size of the erythema at the time of lesion onset  (M  2 for the GV group and 267 cm  2 for the MVPD group). The reasons for this difference in M= 133 cm the erythema size is unknown but could be related to the small sample size. However, it is known that the size of the erythema is related to the size of the treatment field and to the total dose of radiation received (Bloomer et al, 1 975; Hassey et al, 1 982; Malkinson et al, 1 981; Wang, 1991). Therefore, the investigator assessed whether or not differences existed between the two groups in terms of these RT parameters at the time of lesion onset and when the lesions were at their maximum size. The results of these comparative analyses indicated that the two study groups were comparable. In conclusion, the two study groups were equivalent in terms of most of the important demographic and clinical factors. Evaluation of the Study Outcomes The size of the lesion and erythema were measured with the Smith and Nephew flexible grid described in Chapter 3.  Although, this  procedure provided an accurate evaluation of these outcomes it was time consuming and led to some difficulties in distinguishing the exact margins of the lesion, especially when reepithelialization started at the lesion rim; a problem that was also noted by Bryant (1992). It is  62 therefore suggested that a simpler method such as the sum of the two largest perpendicular axis be used as a measurement method in future studies. The lesion size and grade of healing were evaluated at least 2 to 3 times a week using the procedures described in Chapter 3 under the subheading titled “Data Collection Instruments”. The investigator found that these evaluation time periods were sufficient to provide a good estimation of the number of days it took for each of the lesions to move from one grade to the next grade. If an absolute precise determination was required daily assessments would be required.  The use of the  “grade of healing scale” accurately assessed the healing process. The characteristic of the erythema was assessed using the colour grouping described in Chapter 3. Although GV may interfere with the evaluation of the colour of the erythema, this problem was overcome by evaluating the skin around the open. lesion. Discomfort, defined as a burning, itchiness, pulling or tenderness experienced by patients at the lesion site, was measured with the VAS. Published papers indicated that VAS may be difficult to use especially with older patients (Jensen, Karoly & Braver, 1986; Joyce, Zutchi, Hrubes & Mason, 1975). In this study, the majority of patients were not familiar with the VAS and required some explanation. explanation,  Following the  all understood how to use the instrument and had no  63 difficulty in reporting their discomfort. The characteristics of exudate were assessed using a scale based on the literature regarding RISR (see Chapter 3).  A milky yellowish  exudate which was not included in the scale used in this study, was noted in all lesions at some time during the healing process.  Bryant  (1992), mentions that this type of exudate, is normal in the healing process. Further studies are needed to assess exudate from RISR. The conceptual framework underlying this study, the healing process and the factors that either enhance or impede this process, guided the evaluation of the study results in terms of factors to consider when evaluating the equivalence of the two groups and the healing rates of the two groups. The framework identifies that skin closure primarily takes place by cell migration across the lesion bed.  The principles  underlying the effectiveness of the MVPD indicated this was the rationale for the faster healing rates seen in this study. The conceptual framework indicates that factors such as the excessive dryness of the lesion bed could impede the healing process, therefore the dry environment  created  by  the  GV  probably  interfered  with  the  reepithelialization of the tissue, slowing the healing process. Summary The characteristics of the sample, the findings related to the two hypotheses, methodological considerations and discussion of the results  64 have been presented in this chapter in relation to the theoretical framework and other research studies. The sample was comprised of 9 subjects between the ages of 41 and 70 years. The sample is representative of head and neck cancer patients in the province of B.C..  The equivalence of the two study  groups in terms of: age; RT plan parameters; skin condition; and discomfort levels at the lesion site was determined prior to testing the hypotheses. The healing rate of the lesions were analyzed from the day of onset to complete lesion healing as well as from when the lesions were at their maximum size until complete healing. Level of discomfort, described as a burning, itchiness, pulling or tenderness sensations at the lesion site, were analyzed at two time periods during the study (24 hours after the start of the study treatment and when the lesions were at their maximum size). The two study groups were equivalent with the exception of size of erythema at lesion onset. The results of this study confirm that: (1) the open skin lesions treated with MVPD healed significantly faster than lesions treated with GV as indicated by the healing rates from lesions onset to complete healing and from maximum lesion size to complete healing; (2) the healing rate of lesions treated with MVPD was faster once the process of reepithelialization has been initiated; and (3) the level of discomfort was significantly lower in patients treated with MVPD  65 24 hours after beginning the treatments and when the lesions were at their maximum size. The results of the study were generally consistent with the limited published papers on the subject.  66  CHAPTER FIVE Summary, Conclusions, Implications and Recommendations Introduction This  study  was  designed to  examine  and  compare  the  effectiveness of GV and MVPD in promoting healing of an open skin lesion and reducing the level of discomfort at the lesion site.  An  overview of the study is presented in this chapter followed by conclusions, implications for nursing practice, and recommendations for future research. Summary A review of the literature revealed that various methods are used for the care of open lesions secondary to RT. However, only two studies were found addressing the healing rate and level of discomfort in relationship to specific skin care methods (Margolin et al, 1 990; Shell et al, 1986). This  randomized  controlled study  was conducted  with  a  convenience sample of 9 patients with head and neck cancer currently receiving RT as a primary treatment were included in this study. Patients were enro led into the study at the onset of an open skin lesion and were randomized to either the GV or MVPD skin care study groups. The age range of the patients was 41 to 70 years (M  =  53.6). The groups were  67 equivalent in terms of age, RT plan parameters, skin condition and level of discomfort at the time of lesion onset. The results of the study, statistically analyzed with  =  0.05,  supported the two hypotheses proposed in this study. Lesions treated with MVPD demonstrated a significantly faster healing rate than did those treated with GV at two points during the study: (1) from lesion onset to complete healing; and (2) from maximum lesion size to complete healing.  The results also indicated that the rapidity of the  healing rate observed in the MVPD group occurred during the phases of the healing process when reepithelialization was the most active. The patients treated with MVPD experienced significantly lower levels of burning, itchiness, pulling and tenderness at the lesion site 24 hours after starting the study treatment and when their lesions were at maximum size than the patients treated with GV. The reasons underlying the discomfort results seem to be related to the two different modes of action associated with the products; moist versus dry. The clean moist healing environment created by the MVPD significantly reduced the patients levels of discomfort, whereas the dry environment created by the GV did little to reduce the patient’s level of discomfort and at times even enhanced it. Neither of the two skin care treatments appeared to have an effect on limiting the extent of the lesion. The damaging effects of the RT on  68 the skin occurred regardless of the two study treatments. In addition, the results indicated that one of the main considerations related to the size of the lesions appeared to be the size of the RT field rather than the dose of radiation received, when the total dose of radiation exceeded 4,000 cGy. Conclusions Due to the convenience method of sampling and the small sample size, the results of this study cannot be generalized.  However, the  findings of this study suggest a faster healing rate and lower levels of discomfort are associated with moist healing methods rather than dry. Implications The findings of this study provide important implications for nursing practice, education and theory. First, the study results suggest that skin reactions secondary to RT are a major side effect for patients undergoing high dose RT. An awareness of when and to what extent these skin reactions occur can assist nurses to plan appropriate interventions. The results also indicate that MVPD has a role as a standard treatment for the management of skin lesions secondary to RT, involving the epidermis and the dermis and suggest that the use of GV as a skin care treatment for these same lesions should be questioned. The results can be used by nurses in the development of a standardized approach to  69 skin care management for oncology patients undergoing RT. The current treatments for all types of radiation induced skin reactions, in the province of B.C, are based on the belief that dry healing methods will promote faster healing rates. The results of this study indicate there is maybe a lack of understanding in those individuals currently treating lesions secondary to RT of the beneficial effects of moist healing methods in the care of these lesions. An awareness of the principles of moist healing can assist the nurse in directing care strategies with the goals of decreasing the healing time and reducing patient discomfort. Open lesions secondary to RT in this study occurred during the last week of treatment or within the first two weeks following. This means that the majority of the lesions occurred before the next follow-up appointment leaving the patient to cope with this side effect on their own. Patients need to be aware of the early signs of skin breakdown and how to seek assistance. Nursing has a major role in providing this education to patients.  The provision of this information may help  patients to identify problems early thereby, facilitating the use of timely interventions. The establishment of a symptom management follow-up appointment system for patients to see nurses would increase early identification and treatment of problems and help minimize the need for hospitalization for more severe symptoms. Itchiness of the skin is a common side effect experienced by  70 patients throughout their RT. The results indicate that patients in both study groups at the time of lesion onset, experienced moderate levels of itchiness.  Following treatment with MVPD patients experienced  dramatic relief. This observation suggests that MVPD may have some effect on reducing itchiness prior to the occurrence of a lesion. The results also provide valuable information for nursing regarding the importance of evaluating not only the rate of healing between different skin care products but also the need to consider the patient’s comfort and acceptability of the treatment. The withdrawal of patients from the GV group was due to the negative properties associated with the product. Even if GV had promoted a faster healing rate, which it did not, the discomfort associated with the treatment limits its acceptability. Caregivers in general when evaluating the effectiveness of different treatments, must consider the impact on quality of life.  This is  extremely important for cancer patients undergoing multiple and/or lengthy treatment programs with numerous associated side effects. The findings also have implications for nursing education. In order for nurses to assess the effect RT has on the skin and determine the most appropriate treatment for these skin reactions she/he must posses advanced knowledge in the areas of: (1) radiobiology; (2) the structures, functions and physiology of the skin; (3) the relationship between the effects of RT on the cellular structure and tissues of the skin; (4) the  71 healing process; and (5) the principles underlying the various skin care methods and products. Cancer treatment centres must take the lead in preparing oncology nurses who can predict, minimize and identify strategies to prevent and treat these skin reactions to achieve positive patient outcomes. A grasp of all of these areas of knowledge and their application should enhance the problem solving ability of nurses to deal with simple and complex skin care situations. Finally, the theoretical framework used to guide this study provides direction for understanding the relationship between the effects of RT on the skin, the principles of healing and the various factors that influence the healing process. The theoretical framework enables nurses to understand the positive benefits of moist healing methods compared to dry methods and provides guidance to develop a consistent approach to the care of radiation induced skin reactions. Use of this framework may also guide further refinement of general skin care treatments. Recommendations for Further Research Findings of this study suggest ideas for further research in a number of areas. 1.  The development of consistent evaluation tools are needed to systematically assess skin care treatments. (i).  Further refinement of the method of assessing the  phases of the healing process, in terms of grades of  72 healing, is required. (ii). Further testing and refinement of the method used to evaluate the characteristics of erythema and exudate is required. (iii).  Further testing and refinement of the components  chosen to evaluated the level of discomfort are required. 2.  Given the small sample size and the convenience method of sampling, this study should be replicated with a larger sample to substantiate the findings related to rate of healing and discomfort levels.  3.  Furthermore additional control studies comparing MVPD with other skin care methods, besides GV, are needed to determine the best treatment for open skin  lesions  secondary to RT. 4.  Exploratory studies evaluating the role of MVPD in early RISR are required to investigate more specifically its role in preventing open skin lesions and reducing discomfort levels. In conclusion, it is hoped that further research will be conducted  to increase the body of knowledge concerning skin care strategies for RISR. The aim of this research should be directed towards limiting the extent of the tissue damage, promoting faster healing rates, minimizing discomfort and promoting self maintenance by the patient.  73  References Barnett, A., Berkowitz, R.L., Mills, R., & Vistness, L.M. (1983). Comparison of synthetic adhesive moisture vapour permeable and fine mesh gauze dressings for split-thickness skin graft donor sites. The American Journal of Surgery, 145, 379-381. Berner, M., & Rotenberg, G. (1990). The Canadian medical association guide to rrescrijtion and over the counter drugs. Montreal: Reader’s Digest. Bloomer, W., & Hellman, S. (1975). Normal tissue responses to radiation therapy. The New England Journal of Medicine, 293(2), 8083. British Columbia Cancer Agency. (1992). British columbia cancer agency: Annual report. Vancouver, B.C.: Author. Bryant, R.A. (1992). Skin pathology. In R. Bryant (Ed). Acute and chronic wounds: Nursing Management. (pp.10-25). Toronto: Mosby Year Book. Community Outlook. (1987). Wound care: Antiseptic solutions. Community Outlook, April, 31-32. Cunon, C.B. (1985). Physiology of wound healing. In J. Dagher. Cutaneous wounds. (pp. 1-22). New York: Futura Publishing Company. Dini, D., Macchia, R., Gozza, A., Bertelli, G., Forno, G., Guenzi, M., Bacigalupo, A., Scolaro, R., & Vitale, V. (1993). Management of acute radiodermatitis. Cancer Nursing, 16(5), 366-370. Dinner, M., Peters, C., & Shever, J. (1979). Use of a semipermeable polyurethane membrane as a dressing for split skin graft donor sites. Plastic Reconstruction Surgery, 64, 112-114. Doughty, D. (1988). Management of pressure sores. Journal of Entersotomal Therapy; 15, 39-44.  74 Doughty, D. (1992). Principles of wound healing and wound management. In R. Bryant (Ed). Acute and chronic wounds: Nursing management. (pp.32-61). Toronto: Mosby Year Book. Fajardo, L.F., & Berthrong, M. (1981). Radiation injury in surgical pathology. Part Ill: Salivary glands, pancreas and skin. The American Journal of Surgical Pathology, 5(3), 279-296. Farley, K.M. (1991). Cornstarch as a treatment for dry desquamation. OncoIov Nursing Forum, 18(1), 134. Franklin, M.G. (1991). Nursing care of radiation-induced desquamation of the orbit. Oncology Nursing Forum, 18, 786. Frogge, M.H. (1982). Promoting wound healing in the irradiated patient. Association of Operating Room Nurses Journal, 35(6), 10881093. Glass, G.V. & Hopkins, K.D. (1984). Statistical methods in education and psychology (2nd ed). New York: Prentice-Hall. Hassey, K.M., & Rose, C.M. (1982). Altered skin integrity in patients receiving radiation therapy. Oncology Nursing Forum, (4), 44-50. Hassey, K.M. (1 987). Skin care for patients receiving radiation therapy for rectal cancer. Journal of Entersotomal Therapy, 14, 1 97-200. Hilderley, L. (1983). Skin care in radiation therapy: A review of the literature. Oncology Nursing Forum, j(1), 51-56. Hinman, C. & Mailback, H. (1 963). Effect of air exposed and occlusion on experimental human skin wounds. Nature, 200, 377-379. Hunt, T, & Dunphy, E. (1 979). Fundamentals of wound management. New York: Appleton-Century-Crofts. James, J.H., & Watson, A.C.H. (1 975). The use of opsite, a vapour permeable dressing, on skin graft donor sites. British Journal of Plastic Surgery, 28, 107-110. Jensen, M.P., Karoly, P., & Braver, 5. (1986). The measurement of clinical pain intensity: A comparison of six methods. Pain, 27, 117126.  75 Joyce, C.R.B., Zurchi, D.W., Hrubes, V & Mason, R.M. (1975). Comparison of fixed internal and visual analogue scales for rating chronic pain. Europena Journal of Clinical Pharmacology, , 41 5-420. King, K.B., Nail, L.M., Kreamer, K., Strohl R.A., & Johnson, J.E. (1985). Patients’ descriptions of the experience of receiving radiation therapy. Oncology Nursing Forum, 12(4), 55-61. Kelly, P.P., &Tinsley, C. (1981). Planningcareforthe patient receiving external radiation. American Journal of Nursing, 81, 338-342. Kottra, C.J. (1982). Wound healing in the immunosuppressed host. AORN Journal, 35(6), 1142-1148. Lingner, C., Rolstad, B.S., Wetherill, K., & Danielson, S. (1 984). Clinical trail of moisture vapour-permeable dressing on superficial pressure sores. Journal of Entersotomal Therapy, 11, 147-149. Malkinson, F.D., & Keane, J.T. (1981). Radiobiology of the skin: Review of some effects on epidermis and hair. Journal Investigative Dermatology, 77(133), Margolin, S.G., Breneman, J. C., Denman, D.L., LaChapelle, P., Weckback, L., Aron, B.S. (1990). Management of radiation-induced moist skin desquamation using hydrocolloid dressing. Cancer Nursing, 13(2), 71-80. McCaffery, M. & Beebe, A. (1989). Pain clinical manual of nursing practice. Toronto: C.V. Mosby Company. McGowan, K.L. (1989). Radiation therapy: Saving your patient’s skin. RN, 52(6), 24-27. Moshakis, V., Fordyce, M.J., Griffiths, J. D., & McKinna, J. A. (1984). Tegadern versus gauze dressing in breast surgery. The British Journal of Clinical Practice, 38, 149-1 52. Murphy, M. (1962). Radiation therapy. Philadelphia: WB Saunders Company. Oberst, M.T., Hughes, S.H., Chang, A.S. & McCubbin, M.A. (1191). Self-care burden, stress appraisal, and mood among persons receiving radiotherapy, Cancer Nursing, 14(2), 71-8.  76 Okun, M., Edelstein, L., Fisher, B. (1988). Gross and microscopic pathology of the skin volume 1 (2nd ed). Canton, Ma: Dermatopathology Foundation. Orsted, H. (1 989). Radiation skin reaction. The Canadian Nurse, 85(9), 30-31. Overgaard, M., Bentzen, S.M., Christensen, J.J., Hjollund Madsen, E. (1 987). The value of the NSD formula in equation of acute and late radiation complications in normal tissue following 2 and 5 fractions per week in breast cancer patients treated with postmastectomy radiotherapy. Radiotherapy Oncology, 9, 1-12. Pickering, D.G.L. (1993). (A report of the use polyethylene oxide hydrogel in desquamative radiation skin reactions). Unpublished raw data. Pineau, D. (1990). Radiation reaction. The Canadian Nurse, 86(1), 6. Ratliff, C. (1 990). Impaired skin integrity related to radiation therapy. Journal of Enterostomal Therapy, 17,(5), 1 93-1 98. Roof, L.M. (1991). The use of Vigilon primary wound dressing in the treatment of radiation dermatitis. Oncology Nursing Forum, 18(1), 133-134. Schottenfeld, D. & Fraumeni J.F. (1982). Cancer epidemiology and prevention. Toronto: W.B. Saunders. Schwade, J., & Lichter, A. (1982). Management of acute effects of radiation therapy. In Carter, S., Gladstein, E., & Livingston, R. (Eds). Principles of cancer treatment (pp. 221-220). New York: McGraw-Hill Book Company. Seymour, R.A. (1982). The use of pain scales in assessing the efficacy of analgesics in post-operative dental pain. European Journal of Clinical Pharmacology, 23, 441-444. Shell, J.A., Stanuta, F., & Grimm, J. (1986). Comparison of moisture vapour permeable (MVP) dressings to conventional dressings for management of radiation skin reactions. Oncology Nursing Forum, 13(1), 11—16.  77 Sheridan, C.A., & Jackson, B. (1989). Clinical safety and efficacy evaluation of a hydoactive hydrocolloid dressing in the care of cancer patients. Journal of Enterostomal TheraDy, i (5), 21 3-218. Sitton, E. (1 991). Early and late radiation-induced skin alterations. Part I: Mechanisms of skin changes. Oncology Nursing Forum, 19(5), 801-807. Sitton, E. (1992). Early and late radiation-induced skin alterations. Part II: Nursing Care of irradiated skin. Oncology Nursing Forum, i(6),907-91 2. Springhouse Corporation. (1991). Nursing 92 drua handbook. Springhouse, Pennsylvania: Author. Strohl, R.A. (1988). The nursing role in radiation oncology: Symptom management of acute and chronic reactions. Oncology Nursing Forum, 15(4), 429-434. Strohl. R.A. (1 989). Radiation therapy for head and neck cancers. Seminars in Oncology Nursing, 5(3), 166-73. Thomson, L. (1980). Side-effects of radiotherapy. Nursing Times, 76, 877-881. Troetschel, M.A. (1991). Radiation-induced inframammary moist desquamation. Oncology Nursing Forum, 18(4), 786. Walker, V.A. (1982). Skin care during radiotherapy. Nursing Times, 13 (8), 2068-2070. Walter, J. (1 977). Cancer and radiotheraDy: A short guide for nurses and medical students (2nd ed.). New York: Churchill Livingstone. Wang,C.C. (1991). Radiation therav for head and neck neoDlasms: Indications, techniques and results. Littleon, Mass: Year Book Medical Publishers Inc. Wilson, C. & Strohl, R. (1 982). Radiation therapy as primary treatment for breast cancer. Oncology Nursing Forum, (1), 12-15.  78 Winter, G.D. (1 962). Formation of the scab and the rate of epithelialization of superficial wounds in the skin of the young domestic pig. Nature, 19I 293-294. Winter, G.D. (1964). Movement of epidermal cells over the wound surface. In W. Montagna, & R. Billingham (Ed.). Advances in biology of skin, volume 5 (pp.113-127). New York: Pergamon Press Book McMillian Company. Wood, E., & Blada, P. (1985). The human skin: Studies in biology #1 64. London: Edward Arnold, Institute of Biology. Woodtli, M. A. & Van Ort, S. (1991). Nursing Diagnoses and functional health patterns in patients receiving external radiation therapy: Cancer of the head and neck. Nursing Diagnosis, 2(4), 171-80. Yasko, J.M. (1983). Guidelines for cancer care: Svmrtom management. Reston, Virginia: Reston Publishing Company, Inc. Yasko, J.M. (1 992). Care of the patient receiving radiation therapy. Nursing Clinics of North America, 17, 631-648.  I—--—  *  101  EE*EEEHEEEEEEEEEEE  ;  I4i  ::::zzz:: 1 ::::::::::::  Li  C)  -o -‘ 0 a  CD  Cl)  0  0.  1  )  x  -I, CD  CD  z CD  0  CD  3  Cl)  x  0  V V CD D  CD  80 Appendix B Assessment Flow Sheet —  Appendix B  ASSESSMENT FLOW SHEET DATE (IDm  DATE ON STUDY A)  ERYTHEMA •severity 0 = none, 1 = Ihint 2 =_bright, 3 = deep purple • area (cm x cm)  B)  EXUDATE •type’ npne, 1 = serous 0 2 = sero-sang, 3 = sang 4 = purulent • amount (cm x cm)  C)  SMEAR TAKEN (yes/no)  D)  OPEN LESION • size (cm x cm)  E)  DISCOMFORT •_burning_(0-10)  •  • itchiams (0-10) • pulling (0-10) • tenderness (0-10) • other (0-10) F)  SIDE EFFECTS RELATED TO TREATMENT  G)  OTHER (0-10)  H)  DAILY SKIN CARE  Data Collector’s Initials:  ID #:  81 Appendix C  Skin Care Protocol for the Aprlication of Gentian Violet  Procedure for the application of Gentian Violet to an open lesion: 1. Thoroughly cleanse the open lesion with sterile saline. 2. Using a sterile swab stick apply the gentian violet lightly to the open lesion and the immediate surrounding tissue, working from the inner lesion area in a circular motion to the surrounding area. If a second swab is required a new sterile swab is to be used. 3. The open lesion after the application of Gentian Violet is left open to the air. 4. Record the lesion size by carefully tracing around the lesion edges using an Op-Site, Flexigrid sheet.  82 Appendix D Skin Care Protocol for the Application and Care of Open Lesions Using Moisture Vapour Permeable Dressings Procedure for the Application of Op-Site, Flexigrid: 1.  The open lesion and surrounding skin area should be thoroughly cleansed with sterile saline and dried.  2.  A border of at least 2 cm must be maintained around the open lesion. Larger lesions may be covered using 2 sheets of Op-Site, Flexigrid overlapping by at least 1 cm.  3.  Remove the backing from the dressing, hold the dressing by its carrier and remove the paper handle.  4.  Position the transparent dressing over the centre of the lesion and adhere it to the skin surrounding the lesion making sure all four corners of the dressing are secured.  5.  Record the lesion size by carefully tracing around the wound edges. Remove the grid. This procedure can be repeated to provide a graphic history of the lesions size. Indications for need to remove the Op-Site, Flexigrid are: loosing of the dressing from the skin. leakage of exudate from the edges of the dressing. Procedure for the Removal of the Op-Site, Flexigrid: -  -  1.  Hold the dressing down and gently stretch the Op-Site Flexigrid film parallel with the skin. Repeat until the whole dressing is removed.  2.  For particularly fragile skin, the dressing may also be eased off gently with warm soapy water.  Procedure for the removal of excessive exudate that is threatening to lift the dressing: 1.  Remove excess exudate with a syringe using an aseptic technique.  2.  Patch the puncture site with another small piece of Op-Site, Flexigrid.  83 Appendix E Personal and Medical History Form  PERSONAL AND MEDICAL HISTORY FORM  —  I Personal History ID  Code #:  Sex:  —  Residence:  Language:  DOB:  II Medical History and Radiation Therapy Treatment Information Date Diagnosed:  Tumour Site:  Previous Radiation Therapy: D Yes  No  Previous Head & Neck Surgery: a Yes  a No  Type:  Date:  Total Dose:  Field Area:  Radiation Treatment Plan, Site: Number of Fractions:  Total Dose:  Site:  Date:  Breaks: a Yes  Completed:  Start Date:  Stopped: Started:  Why: Medications:  Diabetic:  Diagram of Radiation Treatment Field and Site of Open Lesion(s)  4  a No  Yes  Hx P.V.D.: a Yes  a No  III Skin Assessment  History of Skin Problems: Allergies  Acne  Cancer  Other Skin Care Routine: Soap  Lotion  Shaving  Cologne  Other  IV Study Data  Start Date: Stop Date: Comments:  Randomization Date: Completed Treatment: a Yes  MVPD a a No  Why?:  GV a —  a No  84 Appendix F Grade of Healing GrouDings  Grade 1  No reepithelialization present.  Grade 2  Small sparse or spotty areas of reepithelialization present.  Grade 3  Larger areas of reepithelialization. The smaller previous areas are now joining together to form larger areas.  Grade 4  Complete reepithelialization or complete healing of the lesion.  85 Appendix G Colour Groupings Measuring Erythema 0= None. No change to skin colour.  1 = Faint. A transparent slight reddening of the skin colour that does not fade with time,  2 = Bright. A definite opaque reddening of the skin. The colour is bright and usually shiny in nature with edema noted,  3 = Deep Purple/Red. A dull deep redc.ish/purple colour. i r. brightness of the previous level is gone and replaced by a overall dull red.  86 Appendix H Exudate Grouiing  None  No exudate is present from the lesion  Serous  A clear transparent fluid present in and around the lesion.  Serous-sanguineous  A faint reddish transparent fluid in and around the lesion.  Sanguineous  A bloody opaque fluid in and around the lesion.  Prurient  A greenish fluid in and around the lesion may also have an odour.  87 Appendix I Page 1 of 3 Patient Information and Consent Form Comparison of Moisture Vapour Permeable Dressings and Gentian Violet Application for the Management of Open Skin Lesions Secondary to Radiation Therapy in Head and Neck Cancer Patients My name is Barbara Korabek, I am a Registered Nurse currently in the Masters of Nursing program at the University of British Columbia. I have worked in a cancer treatment centre for the last eight years. I am currently conducting a study evaluating different types of treatment for skin reactions that have resulted during the course of radiation therapy. The purpose of this study is to compare two types of treatment used in the care of open skin areas that might occur as a result of radiation therapy. One of the two types of treatments used in this study is the application of Gentian Violet to the open skin area two to three times a day. Gentian Violet is a purple liquid that is applied directly to skin using sterile swabs. The second treatment is the use of a thin clear dressing that is applied directly to the open skin area and remains in place for several days. Both types of treatment have been previously used in the care of skin reactions and to date, there has been no evidence of side effects from either type of skin care. It is unknown what percentage of patients receiving radiation therapy will develop a small open area but it is important to note that not all patients do and if you do develop a small open area your radiation therapy will not be compromised in any way. If you do develop a small open area you will be randomly assigned to use one of the two skin care treatments. This means you will have an equal chance of being assigned to use either the Gentian Violet or the clear dressing treatments. If you consent to participate I will see you either before or after your next radiation therapy treatment at the British Columbia Cancer Agency. At that time I will review this document with you and ask you to sign the document. After that I will ask you questions about your general health and skin care practices. I will see you again on your next treatment either before or directly after and then every day until you complete your course of radiation therapy. During these visits I will check your skin area where you are receiving treatment and ask you a few questions regarding your comfort level. If you have an open skin area at the end of your radiation therapy treatment you will be asked to come to the clinic twice a week until  88 Page 2 of 3 your skin heals or for one month. If you do develop an open area once your radiation has completed you are asked to call your attending physician at the Cancer Clinic for instructions on your skin care. The study concludes after skin has completely healed, and! or one month after you began the skin care treatment. I will instruct you or any members of your family you wish about how to use and apply the skin care treatments. While you are on the study all necessary skin care supplies will be provided to you at no cost. While you are on the study, I will see you daily either before or directly following your radiation therapy and then twice a week to assess your skin, ask a few questions related to your comfort level and help you with your skin care. If you agree, skin cultures and a photograph of your skin area will be taken on the first day you start the skin care treatment and then once a week until the study is completed. The study will require approximately 10 to 1 5 minutes of your time each treatment day for the skin assessment, performing the necessary skin care and answering any questions you may have. Although there may be no direct benefit to you participating in this study, the knowledge gained will be important to the future care of this type of skin reaction. Your identity with the information obtained will be kept confidential. To protect this confidentiality an identification number will be used instead of your name on all forms related to the study. The information obtained will only be used for scientific publications, reports, or presentations. Your participation in this study is entirely voluntary. If you decide not to participate or at any time in the future you decide to withdraw from the study, your present and future care at the British Columbia Cancer Agency will not be affected.  89 Page 3 of 3 Evaluation of Gentian Violet and Moisture Vapour Permeable Dressing in the Care of Open Skin Lesions Secondary to Radiation Therapy, Patient Information and Consent Form. By signing this consent form, I indicate that I fully understand the purpose of the study and my participation in it. I acknowledge that I have received a copy of the information and consent form. I have had questions answered to my satisfaction and I agree to participate in the study. I may contact Barbara Korabek at 877-6000 local 2503 or 9370802 if I have further questions or require additional information. I may also contact her research supervisor who is, Dr. A. Hilton at University of British Columbia School of Nursing, 822-7498 if I have any questions or concerns.  (Witness)  (Date)  (Signature)  (Date)  90 Appendix J  Skin Culture Procedures  Procedure for obtaining a wound culture: 1. Thoroughly cleanse the open lesion with sterile saline. 2. Do not swab over hard eschar. 3. Use a sterile culture swab. 4. Rotate swab and swab wound in a back and forth motion across the wound.  91 Appendix K Procedure for Photoqrarhs  1. 2. 3. 4. 5. 6. 7.  Use camera on manual settings, turn camera on. Turn flash to TTL. Line up the white markings on the camera lens and polarizer. Take a regional photo (1:7 magnification, F-stop 5.6). Take a close-up photo (1:4, 8). Use same magnifications and orientation during each visit for consistency. Take two photos at each orientation.  

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