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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 VAPOURPERMEABLE DRESSINGS FOR THE MANAGEMENT OF OPEN SKIN LESIONSSECONDARY TO RADIATION THERAPY FOR HEAD AND NECK CANCERbyBARBARA JOYCE KORABEKDiploma in Nursing, Mount Royal College, 1976BScN., University of Alberta, 1986A Thesis Submitted in Partial Fulfilment ofthe Requirements for the Degree ofMaster of Science in NursinginThe Faculty of Graduate StudiesSchool of NursingWe accept this thesis as conforming7/THE UNIVERSI1* OF BRITISH COLUMBIASeptember, 1994Barbara Joyce KorabekIn presenting this thesis in partial fulfillment of therequirements for an advanced degree at the University of BritishColumbia, I agree that the Library shall make it freely availablefor reference and study. I further agree that permission forextensive copying of this thesis for scholarly purposes may begranted by the head of my department or by his or herrepresentatives. It is understood that copying or publication ofthis thesis for financial gain shall not be allowed without mywritten permission.(Signature)_____________________Department of____________________The University of British ColumbiaVancouver, CanadaDate t2z y/i99IIABSTRACTA randomized controlled pilot study of 9 patients who developed an openskin lesion secondary to radiation therapy for primary head and neck cancerwas initiated. The purpose of this pilot study was to examine and compare theeffectiveness of gentian violet (GV) and moisture vapour permeable dressing(MVPD) in promoting healing and reducing discomfort at an open lesion sitesecondary to radiation therapy.Patients were randomly assigned to either the gentian violet or moisturevapour permeable dressing group at the time of lesion onset. The skin caretreatments were evaluated with respect to the rate of lesion healing anddiscomfort 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 noevidence of infection in any of the lesions.The results of the study, statistically analyzed using the Mann-WhitneyU test with = 0.05, supported the two hypotheses proposed in this study.Lesions treated with MVPD demonstrated a significantly faster healing rate thandid those treated with GV ( U = 8, = 0.05). The results also indicated thepatients treated with MVPD experienced significantly lower levels of burning,itchiness, pulling and tenderness (U = 9, < 0.001) at the lesion site 24hours after starting the study and when their lesions were at maximum size.IIIAlthough the sample was small the results of this study tend to indicatethat in the clinical practice setting, MVPD can be used effectively as atreatment for skin lesions, secondary to RT, involving the epidermal andportions of the dermal layers of the skin.ivTable of ContentsAbstract iiTable of Contents ivList of Tables viiList of Figures viiiAcknowledgements ixCHAPTER ONE: INTRODUCTIONBackground to the Problem 1Problem Statement 3Purpose 3Conceptual Framework 3Hypotheses 7Definition of Terms 7Open Skin Lesion Secondary to Radiation Therapy 7Complete Lesion Healing 8Discomfort at the Lesion Site 8Gentian Violet 8Moisture Vapour Permeable Dressing 9Significance of the Study 9Organization of the Thesis 10CHAPTER TWO: REVIEW OF THE LITERATUREIntroduction 11The Skin 11Head and Neck Cancer 14Radiation Therapy and Its Effect on the Skin 15Assessment of Skin Reactions to Radiation 1 7Treatments of Radiation Induced Skin Reactions 19Moisture Vapour Permeable Dressings 20Gentian Violet 24Summary of the Literature Review 26VCHAPTER THREE: METHODSIntroduction 27Research Design 27Selection Criteria 27Instruments for Data Collection 29Pre-test 33Procedures 33Data Analysis Procedures 35Assumptions 36Limitations 37Procedure for the Protection of Human Rights 37Summary of the Methods 38CHAPTER FOUR: PRESENTATION AND DISCUSSION OF FINDINGSIntroduction 39General Characteristics of the Sample 39Socio-demographic Characteristics 39Medical and Radiation Therapy Characteristics 40Skin Condition at Lesion Onset and MaximumLesion Size 42Discomfort Level at Lesion Onset 43Equivalence of the Groups 45Hypothesis One: Regarding Rate of Healing 45Hypothesis Two: Related to Discomfort Levels 49Discussion 53Findings Related to the Hypotheses 57First Hypothesis 57Second Hypothesis 58Methodological Considerations 60Representativeness of the Sample 60Equivalence of the Study Groups 60Evaluation of the Study Outcomes 61Summary 63CHAPTER FIVE: SUMMARY, CONCLUSION, IMPLICATIONS,AND RECOMMENDATIONSIntroduction 66Summary 66Conclusions 68Implications 68Recommendations for Further Research 71viREFERENCES 73APPENDIXESAppendix A. Smith and Nephew Flexigrid 79Appendix B. Assessment Flow Sheet 80Appendix C. Skin Care Protocol GV 81Appendix D. Skin Care Protocol MVPD 82Appendix E. Personal and Medical History Form 83Appendix F. Grade of Healing 84Appendix G. Colour Groupings Measurement Erythema 85Appendix H. Exudate Groupings 86Appendix I. Patient Information and Consent Form 87Appendix J. Skin Culture Procedures 90Appendix K. Procedure for Photographs 91viiList of TablesTablePage1 The Skin Reaction to Radiation Grading Scale 192 Products Used in the Care ofRadiation Induced Skin Reactions 213 Demographic, Radiation Therapy and MedicalCharacteristics of the Sample 414 Skin Lesions Characteristics at Onset andMaximum Lesion Size 445 Erythema and Exudate Characteristics atLesion Onset and Maximum Lesion Size 456 Levels of Discomfort at Three Time PeriodsDuring Study 467 Healing Rates From Onset and MaximumLesion Size to Complete Healing 498 Duration of Healing in Days in Terms of Gradeof Healing 51VIIIList of FiguresFigure PageDiagram of the Structure of the Human 1 2SkinII Design of the Study 28III Level of Burning at Lesion Onset, 24 hourson Study and When Lesion was at Maximum Size 52IV Level of Itchiness at Lesion Onset, 24hours on Study and When Lesion was atMaximum Size 54V Level of Pulling at Lesion Onset, 24hours on Study and When Lesion was atMaximum Size 55VI Level of Tenderness at Lesion Onset, 24hours on Study and When Lesion was atMaximum Size 56ixAcknowledgementsI would like to thank the members of my thesis committee, Dr. AnnHilton (chairperson), Dr. Michelle Deschamps and Professor Anne Wyness fortheir patience and guidance throughout the past years.I wish to extend a special thanks to Zdenek, my husband, for continuingto be a source of encouragement and support.I wish to thank all the staff on the 5th floor and the Surgical Suite atBCCA, for their patience and understanding until I finished this project. Finally,I would like to acknowledge the individuals who so generously took the timeto participate in this study.1CHAPTER ONEIntroductionBackground to the StudyApproximately 400 patients are diagnosed with head and neck canceryearly in British Columbia (British Columbia Cancer Agency, 1992). In thecourse of their disease, the majority of these patients will receive radiationtherapy (RT) either as a primary treatment to cure the disease or as a palliativemeasure for symptom management (Strohl, 1988). Radiation affects bothnormal and cancerous tissue, producing skin reactions which vary from milderythema to open skin lesions. To date there is no precise data on theincidence of open skin lesions for head and neck tumour patients. However,it is estimated that at least 25% of these patients will experience a radiationinduced 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, oneof the treatments used for open skin lesions secondary to RT is the applicationof 1 % Gentian Violet (GV) solution several times a day to the affected skin area(British Columbia Cancer Agency, 1992). Although no studies have specificallydocumented the properties of GV in RISR, it is assumed that this agent, in2addition to promoting drying of the exudate, has antifungal and antibacterialeffects (Springhouse Corp., 1991) (Sitton, 1992). The benefit of the firstproperty has, however, been questioned by several authors (Hassey & Rose,1 982; Ratliff, 1 990; Walker, 1 982) who believe that dryness of an open skinlesion may inhibit the regeneration of the epidermis by limiting cell movementthat occurs during healing (Hassey & Rose, 1982; Winter, 1964). In addition,some patients find the use of GV to be messy, staining, uncomfortable anddifficult to manage (Sitton, 1992).The availability of Moisture Vapour Permeable Dressing (MVPD) has offeredthe possibility of a new approach in the care of open skin lesions secondary toRT. MVPD (Bioclusive, Op-Site, Tegaderm) are polyurethane clear filmdressings permeable to oxygen and water vapours and impermeable to liquidand bacteria (Barnett, Berkowitz, Mills & Vistness, 1985). The healing propertyof MVPD in clean open skin lesions (graft donor sites, surgical incisions andsuperficial 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 thebacterial contamination and incidence of infection and to accelerate the healingprocess (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 ownstudy, Shell et al (1986) postulated that if MVPD were used in the care of open3skin lesions secondary to RT they would demonstrate the same beneficialeffects as those seen with other partial skin loss lesions.Although MVPD have been used in other centres in the care of open skinlesions secondary to RT, they have not been used in British Columbia for thispurpose. No studies to date have been undertaken to examine and comparethe use of GV and MVPD in terms of promoting healing of open skin lesionssecondary to RT for head and neck cancer or reducing discomfort at theselesion sites.Problem StatementVarious methods of treatment have been suggested for the care of openskin lesions secondary to RT. Both GV and MVPD are currently used to treatopen skin lesions secondary to RT. To date, no studies have examined theireffectiveness in promoting lesion healing and minimizing the level of discomfortat the lesion site.PurroseThe purpose of this pilot study was to examine and compare theeffectiveness of GV and MVPD in promoting healing of skin lesions secondaryto radiation therapy and reducing discomfort at these lesion sites.ConceDtual FrameworkThe healing process of an open lesion, hereafter referred to as lesion, andthe factors that influence the course of healing have provided the underlyingconceptual framework for this study. The healing process is a fundamental4defense mechanism to protect the body against foreign microorganisms and toreplace the lost tissue (Hunt & Dunphy, 1979).When the integrity of the skin is disrupted and a lesion is created, aseries of dynamic events are enacted. Initially the lesion is invaded bypolymorphs as well as macrophages which debride the lesion surface preparingit for the subsequent events of the healing process (Cunon, 1985). Dependingupon the extent of the lesion, two different mechanisms of healing exist;regeneration or replacement of the damaged tissue. Regeneration is thesubstitution of lost tissue with tissue of a similar type, whereas replacement isthe 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 ofthe tissues involved to regenerate; the epidermis and dermis layers of the skinhave the capacity for regeneration. The rationale for this is that epithelial,endothelial, and connective tissue within these layers of the skin can bereproduced (Doughty, 1 992). Epidermal and dermal repair proceedconcurrently; epidermal by reepithelialization and dermal by collagen repair(Doughty, 1992). The critical event in the process of regeneration is thereepithelialization or reestablishment of the normal skin layers and function(Doughtly, 1 992). The salient feature of reepithelialization is that it takes placeprimarily by cell movement (Winter, 1 964); the cells migrate across the openlesion until the lesion is closed. The process of reepithelialization can bevisually observed. It is a process the moves from a state of no epithelialization,5to spotty small areas, to larger areas and finally to complete reepithelializationor complete lesion healing (Cunon, 1985). This process is dependent of theability of the cells to migrate across the lesion bed. The migration of thesecells 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, dermisand deeper structures, such as subcutaneous tissue, a less precise process ofhealing occurs referred to as “replacement” of tissue. Tissue replacement isthe reconstruction of lost tissue with new connective tissue (Cunon, 1985).Several factors may influence the healing process. For example, at acellular level the presence of an infectious state, excessive moisture or drynessin the lesion bed, and the intake of steroids interfere with the inflammatoryresponses and the reepithelialization of the tissues (Doughty, 1992). At asystemic level, an advancing age, impaired nutritional status, and vascularinsufficiency decrease the energy and oxygen supply necessary for thebiochemical reactions that are part of the healing process (Cunon, 1 985).Radiation exposure, which is the main focus of this study, creates anopen skin lesion and then interferes with the healing process by: (1) disruptingthe 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 anexcessively moist lesion thereby limiting cellular movement and promotingbacterial proliferation (Hassey, et al, 1982). Continued daily exposures to6radiation results in observable epidermal and dermal skin reactions which varyfrom alteration in the skin’s pigmentation, to a reddening of the skin, referredto as erythema, and finally to the appearance of open skin lesions (Hassey etal, 1982).The healing process of a lesion can be enhanced by various means suchas protecting the lesion against contamination, friction and trauma; maintaininga clean moist environment; and by ensuring adequate oxygen, nutrition andfluid levels (Doughty et al, 1992).GV enhances healing by acting as a topical pharmacological agent tocontrol superficial skin bacteria and fungi growth. MVPD, on the other hand,acts at two levels: first, by creating and maintaining a clean moist protectivebarrier that enhances cellular migration and limits external bacterialcontamination, (Doughty et al, 1988; Winter, 1964), and then by protectingagainst friction, thereby reducing the chance of further abrasive damage andits associated discomfort. In this study these two treatment interventions, bothof which are directed towards enhancing the healing process, were compared.Lesions resulting from RT are frequently described in the literature asbeing tender and uncomfortable for patients (Malkinson & Keane, 1981; Wang,1991). The reason for this is that when these lesions are created the nerveendings are abraded and exposed to the external environment producing varyinglevels of discomfort. Evaluating the effectiveness of a particular skin caretreatment without determining its effects on the patient’s level of discomfort7would only half measure the quality of the treatment. The treatment techniqueutilized to promote the healing process must also consider maintaining ordecreasing the level of discomfort to be an effective treatment strategy.HypothesesThe hypotheses tested in this pilot study were the following:1. Open skin lesions secondary to radiation therapy in head and neck cancerpatients treated with MVPD will heal at a faster rate than those treated withGV.2. Head and neck cancer patients with an open skin lesion receiving treatmentwith MVPD will describe less discomfort at the open lesion site than patientswho receive treatment using GV.Definition of TermsODen Skin Lesion Secondary to Radiation TherapyAn open skin lesion is an observable skin loss that occurs when the skinis 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 measuredin squared centimetres using the Smith and Nephew Flexigrid (Appendix A) andwas documented on the Assessment Flow Sheet developed for this study(Appendix B).8ComDlete Lesion HealingComplete lesion healing is the complete reepithelialization of a lesion(Doughty, 1 992). Evaluation of healing was done by measuring the lesion sizeand the rate of reepithelialization until complete healing had occurred. Healingrate was determined in days, from the first day an open lesion was observeduntil the day it was completely healed. Reepithelialization was graded on ascale of 1 to 4: (1) no epithelialization or healing present; (2) the presence ofspotty sparse regions of epithelialization; (3) the presence of larger areas ofepithelialization (the small spotty areas are grouping together to form largerareas); and (4) the presence of complete reepithelialization or complete healing(Cunon, 1985).Discomfort at the Lesion SiteDiscomfort is a subjective experience reported by patients when askedto 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 visualanalogue scale. The results were documented on the Assessment Flow Sheetdeveloped for this study (Appendix B).Gentian VioletMethylrosaniline chloride 1 % (gentian violet) is an antifungal andantibacterial solution that is applied directly to the skin.9Moisture Vapour Permeable DressingMoisture Vapour Permeable Dressing is a sterile film dressing made ofpolyurethane covered with a hypoallergenic adhesive on one side. In thisstudy, the MVPD used was Flexigrid Op-site manufactured by Smith andNephew.Significance of the StudyScientific SignificanceThe information obtained from this study supplements the knowledgeconcerning the appropriate strategies for the care of open skin lesionssecondary to radiation therapy. The study provides the information required todetermine the feasibility and merit of conducting a larger study.Practical SignificanceNursing is taking a more active role in the determination of carestrategies for RISR but to date, little scientific evidence is available to guideclinical practice. This pilot study attempted to systematically evaluate twocurrent methods used in the care of open skin lesions secondary to RT, withrespect to their ability to promote healing, decrease the severity of the level ofdiscomfort experienced by patients, and improve their quality of life.The findings of this study will provide knowledge about the healingprocess of lesions secondary to RT. Included in this knowledge will be specificinformation on how moist versus dry skin care treatments actually facilitate the10healing process and at what stage in the healing process the benefits are mostlikely to be seen. In addition, the findings will provide knowledge about twotypes of skin care treatments and the patient’s level of discomfort throughoutthe healing process. This knowledge will assist nurses on how best to treatopen skin lesions secondary to RT with the outcomes of promoting healing anddecreasing the discomfort experienced by the patient. Finally, the results ofthis study will add to the general knowledge related to lesion healing, and howRT affects the skin and the healing process.Organization of the ThesisThis thesis is comprised of five chapters. In Chapter One, thebackground to the problem, problem statement, purpose, conceptualframework, hypotheses, significance of the research, and definitions have beenpresented. In Chapter Two, a review of selected literature pertaining to theidentified research hypotheses will be presented. In Chapter Three, theresearch methods including a description of the research design, data collectiontools, procedures as well as means used for protection of human rights anddata analysis will be described. In Chapter Four, the description of the samplefindings, and a discussion of the results will be presented. The summary,conclusions as well as the implications for nursing practice and research will bepresented in Chapter Five.11CHAPTER TWOReview of the LiteratureIntroductionThe literature review examines both research and non-research basedliterature. The review is divided into five sections: (1) a brief review of headand neck cancer including its epidemiology and treatment; (2) an overview ofthe structure and physiology of human skin; (3) details on the effects ofradiation on the skin; (4) assessment of the RISR; and (5) a critical review ofresearch on the treatments used in the care of RISR with an emphasis on GVand MVPD in the treatment of open skin lesions.The SkinThe skin constitutes a vast protective barrier between man and hisenvironment. It is one of the largest organs in the body, constitutingapproximately one eighth of the weight of a normal individual (Wood & Blada,1 985). The skin is composed of three recognizable layers: the epidermis, thedermis, 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 thecutaneous appendages including the sweat and sebaceous glands, the hair, andthe nails (Okun, Edelstein & Fisher, 1988; Wood & Blada, 1985). Severallayers of cells within the epidermis are recognized histologically. These include12Figure I. Diagram of the structures of the human skin.rmislermisus glandSweat DiSweat gland Nerve Adipose13the stratum basale, stratum spinosum, stratum granulosum, stratum lucidumand finally the stratum corneum. The superficial cells of the outermostcorneum layer are shed and are replaced by new cells that are formedcontinually by mitosis in the basal layer (stratum basale) (Sitton, 1992). Veryfew other body cells have the capability of continually producing new cells(Wood & Blada, 1985). The epidermis and dermis are separated by thebasement membrane, which has a major role in regulating epidermal growththrough the mechanism of diffusion of nutrients from the dermal blood vessels(Sitton, 1991).The dermis arises from the embryonic mesoderm and supports thecutaneous appendages such as hair follicles, sebaceous and sweat glands. Italso contains blood vessels, lymph vessels and nerves (Okun et al, 1 988). Thedermis makes up the bulk of the skin and is composed of a network ofmechanically strong fibres, mostly collagen. It is a tough, resilient tissue thatcushions the underlying organs against mechanical injury and provides nutrientsfor the epidermis and cutaneous appendages (Okun et al, 1988). The dermis,consists of two specific cells, fibroblasts and macrophages, which areresponsible for the production of collagen. Collagen plays a major role in thehealing process, specifically in scar formation and granulation.Beneath the dermis is a layer of loose connective tissue referred to as thehypodermis (Wood & Blada, 1985). It forms a layer of adipose tissue overmost of the body , providing thermal insulation, mechanical protection, and14energy reserve for the body (Wood & Blada, 1985). Any action or mechanismthat disrupts the physiology of the skin can leave the skin susceptible to aninjury. Exposure of the skin to ionizing radiatioh disrupts the normalphysiological activities of the skin making it susceptible to developing an openlesion (Hassey et al, 1982).Head and Neck CancerHead and neck cancer encompasses oral, larynx, pharynx, thyroid andsalivary gland cancers (British Columbia Cancer Agency, 1992). The etiologyof these cancers is unknown but they appear to be more common amongstsmokers and alcohol drinkers (Schottenfeld & Fraumeni, 1982). Head and neckcancers are found in both genders; the male/female ratio is 2-3:1 in mostcountries (Schottenfeld & Fraumeni, 1 982). Generally, the medical treatmentfor these cancers includes surgery, RT and chemotherapy (King, Nail, Kreamer,Strohl, & Johnson, 1985; Kusler, & Rambur, 1992). In early squamous cellcancers , for example, the preferred primary treatment is RT. But wheninvolvement of the lymph nodes is detected, surgical dissection , usuallyfollowed by RT, may be recommended. It is only after radiation and radicalsurgery have failed that chemotherapy is added to the treatment plan in mostsituations (Wang, 1991). Therefore, the majority of patients with head andneck cancer will receive RT at some stage of their disease, placing them at riskfor developing a RISR.RT for head and neck tumour patients is usually given on a 5 day on and152 day off schedule over a 4 to 6 week period. The total dose of radiation isbetween 4,000 and 7,000 cGy (British Columbia Cancer Agency, 1 992). Theloss of taste and appetite as well as mucositis, fatigue, sore throat, hoarsenessand dysphasia are among the common side effects associated with RT (Kinget al, 1985; Wang, 1991; Woodtil & Van Ort, 1991). However, one of themajor side effects observed in patients is varying types of skin reactions (Kinget al, 1985; Wang, 1991). The character and magnitude of the RISR dependsupon many factors including the anatomical site, the quality of the radiation andionization density, total dose of radiation, number of fractions, size of tissueirradiated, vascular supply, as well as the age and general condition of thepatient (Bloomer & Hellman, 1975; Malkinson & Keane, 1981; Walker, 1982).Radiation Theraiw and Its Effect on the SkinRT is the ejection of radioactive and electromagnetic particles in tissue orinside the cells in order to treat cancerous tumours (Bloomer & Hellman, 1 975;Malkinson & Keane, 1981). On a cellular level, radiation causes DNA damagewhich leads to cellular death (Bloomer & Hellman, 1975; Malkinson & Keane,1981). Radiation affects normal and cancerous cells in essentially the samemanner; by attacking cells that have a high mitotic rate, such as skin cells morerapidly. The principle underlying RT is to destroy the cancerous cells whileleaving sufficient normal cells to enable tissue repair, thereby minimizing theside effects associated with the treatment (Malkinson & Keane, 1981; Walter,1977).16Through a feedback mechanism called homeostatic stimulus, normal skincells have the ability to repair damage caused by ionizing radiation (Ratliff,1990). But this repair process requires extended time intervals betweenradiation exposures. The therapeutic level of radiation needed to destroy thecancerous cell growth requires repeated exposures of radiation in a short timeinterval thereby decreasing the ability of normal cells to repair which results inRISR.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 theskin or faint erythema appears. This is due to capillary dilation and an increasein vascular permeability (Bloomer & Hellman, 1975). After the first fewfractions of 200 to 400 cGy, there is an inhibition of mitotic activity in thegerminal cells of the epidermis, hair follicles, and sebaceous glands (Bloomer& Hellman, 1 975). Dry desquamation, characterized by pruritus, scaling, andpeeling in the basal layer becomes apparent due to the suppression of thesebaceous glands and the rapid basal cell production (Hassey et al, 1982).Often an increase in pigmentation is also observed. By the third or fourthweek, a typical bright erythema reaction appears, sharply localized in theradiation field. The skin is red, edematous, warm, and variably tender (Hasseyet al, 1982). Blood vessels in the upper dermis are dilated. Edema isprominent, especially in the upper dermis and there may be small foci of17haemorrhage (Bloomer & Hellman, 1975).When the dose of radiation exceeds 4,000 - 5,000 cGy, which is frequentlythe case with head and neck cancers, the erythema is usually followed by amoist desquamation (Malkinson & Keane, 1981; Wang, 1991). Moistdesquamation is the presence of an open lesion, varying from partial loss of theepidermal to complete loss of the epidermal and dermal layers of the skin thatoccurs as a result of the inability of the basal cells to provide enoughdifferentiated cornified cells (Malkinson & Keane, 1981).In the past, RISR were a treatment limiting complication, but today Withthe use of megavoltage radiation sources such as linear accelerators, the skinis generally spared from developing open skin lesions (Fajardo et al, 1981).However, open skin lesions are still observed in some instances. To date, thereis no precise data on the incidence of open skin lesions secondary to RT forpatients with head and neck cancer. However, based on the researcher’sexperience it is estimated that the majority of head and neck cancer patientshave a reaction that results in some degree of tissue loss during or followingthe course of their RT.Assessment of Skin’s Reaction to RadiationTo date no standardized methods have been developed to assess andquantify the severity of RISR. Most often, simple descriptions such aserythema, dry and moist desquamation have been used (Hassey et al, 1 982;Hilderly, 1983; McGowan, 1 989; Ratliff, 1 990; Sitton, 1992; Troetschel,181991; Walker, 1982). Recently, several attempts have been made to classifyRISR. The Clinical Practice Committee of the Oncology Nursing Society in1 982 described a four level system of impairment which ranges from apotential impairment to the presence of an open purulent skin lesion. Yasko,(1983) on the other hand, established a staging system based on clinicalreactions. Each stage has a corresponding description: Stage I, erythema;Stage II, dry desquamation; and Stage Ill, moist desquamation. The RadiationTherapy Oncology Group (RTOG), developed a scale titled “The Acute RadiationMorbidity Scoring Criteria” which is also based on clinical reactions. This scaledescribes five levels of skin reactions ranging from 0 to 4 where 0 indicates nochange and 4, an ulcerative, haemorrhagic and necrotic lesion.The above methods have been found useful to describe skin reactions inclinical settings. However, they all lack precision when trying to evaluate thesize of an open lesion for research purposes. The scales listed above utilize thebroad category of moist desquamation to describe a RISR that has an open skinlesion present. However, they do not describe specifically the extent orprogression of the tissue damage. Table 1, presents a method that uses a 4point ordinal scale (Overgaard, Bentzen, Chritensen, & Hjollund, 1987). Thisscale describes the severity of the skin reaction in detail as well as theprogression of the reaction, but still does not mention the amount of tissue lossor size of the open lesion in detail, therefore making it ineffective for thisparticular study. A more precise method was developed to measure the exact19Skin Reaction GradingGrade 0 Grade 1ScaleGrade 2 Grade 3size of the open lesion as well as the degree of reepithelialization present.Table 1Radiation Induced___________EndpointMoistdesquamationErythemaTelangiectasisSubcutaneousfibrosisNone 10% 10%-49% 50%None Mild Moderate SevereNone 1 cm2 1-4 cm2 4 cm2None Mild Moderate SevereNote. From “The value of the NSD formula in equation of acute and lateradiation complications in normal tissue following 2 and 5 fractions per weekin breast cancer patients treated with post mastectomy radiotherapy byOvergaard, M. Bentzen, S., Christensen, J. & Hjollund, M., 1987, RadiotheraDyOncology, 50.Treatment of Radiation Induced Skin ReactionsVarious 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 cornstarchto 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 steroidsto reduce itchiness (Kelly et al 1981; Wilson, 1982; Yasko, 1992), andhydrocolloid dressings to control the lesion exudate (Margolin et al, 1990;20Orsted, 1989). Table 2 outlines the various products currently used in thecare of RISR and their mode of action based on the literature. Although theseinterventions are frequently used, no studies have been done to evaluate theirclinical effectiveness in the care of RISR with the exception of hydrocolloiddressings and MVPD (Margolin et al, 1990; Shell et al, 1986).Margolin et al (1990) conducted a non-comparative study evaluatinghealing time, lesion temperature, bacterial growth, and level of discomfort atthe lesion site in 20 patients with open skin lesions secondary to RT. Resultsof this study indicated that the healing process, as measured by number ofdays until complete reepithelialization, was faster with hydrocolloid dressings(13 days) compared to previously reported information on hydrous lanolin gauzedressing (24 days). Results of this study suggested that a moist clean healingenvironment that controls exudate was more effective in promoting the healingprocess than one which only provides a moist healing environment.Moisture Vagour Permeable DressingThe availability of MVPD has offered the possibility of a new approach inthe care of open skin lesions secondary to RT. MVPD are thin clear films ofpolyurethane covered with a hypoallergenic adhesive on one side. These filmdressings are permeable to oxygen and water vapours, and impermeable toliquid and bacteria (Barnett, et al, 1985). They can be removed withoutproducing undue tissue damage and discomfort (Shell, et al, 1 986). MVPD areapplied directly to a clean open skin lesion. They can be used at the first21indication of epidermal erosion and to the point where complete dermalexposure is present.Table 2Products Used in the Care of Radiation Induced Skin Reactions.PRODUCTS MODE OF ACTIONCategory: RISR With Intact SkinTalcum Powder .control pruritusCorn Starch .control pruritusHydrocortisone Cream .control pruritus &decrease inflammationLubriderm .provide moistureVitamin A & D Cream .provide moistureCategory: RISR With Open Skin LesionWet Compresses-Saline cIeanse area-Astringents .control infection-Antibacterial Agents .control infectionMVPD .provide clean moistenvironmentGentian Violet .dry exudate andcontrol infectionBurrows Solutions .cleanse & debrideSilver Sulphadiazine Cream .provide moistenvironment and controlinfection.Hydrocolloid Dressings .provide clean moistenvironment and control exudateHydrogels .control exudate22The goal of action of MVPD is to provide a moist, permeable, cleanenvironment favourable to the normal healing process (McGowan, 1989).Various studies have been conducted to investigate MVPD in the promotion ofhealing, control of bacterial proliferation, and reduction of pain.Winter (1962) demonstrated in animals that the application ofpolyurethane films keeps lesions moist, thereby creating an environment thatpromotes cell movement and enhances lesion repair. These results were alsoobserved in human lesions by Hinman and Mailback (1963). The evaluation ofMVPD in various types of lesions, such as graft donor sites, surgical incisionsand superficial pressure sores also suggested that the dressings decrease thehealing time of a lesion (Barnett, et al, 1983; Moshakis, et al, 1984).James and Watson (1975), conducted a comparative study involving 53patients with split graft donor site lesions. All of the patients received theMVPD skin care treatment and the healing rate and discomfort levels werecompared to the authors’ previous data about skin care methods. However, noconclusions regarding the healing rate were made because of the great variationamong the patients in terms of the thickness of the graft donor site and theprocedures used for obtaining the grafts. The results validated that MVPDpromotes ease of movement at the lesion site without inducing discomfort ortenderness. Staff reported that MVPD were easy to apply but identifiedexudate leakage around the dressings as a disadvantage.23Barnett, Berkowitz, Mills and Vistness (1983) did a randomized study on60 graft donor sites in 25 patients comparing MVPD to a fine mesh gauzedressing with. respect to healing time, pain at the lesion site, occurrence ofinfection and adhesion of the dressing. Results indicated that patients usingMVPD experienced minimal pain compared to patients using the gauzedressing. However, the specific criteria used to evaluate pain were notdescribed. The mean healing time, reported in days to completereepithelialization, was of 6.8 days (S.D. = 2.0 days) for the MVPD group andof 10.5 days (S.D.= 5.5 days) for the gauze dressing group. The authorsreported that there was a much faster healing rate associated with the MVPDthan with the fine mesh gauze dressings but the statistical test used to assesssignificance was not mentioned. Due to a problem in the criteria used toevaluate the dressings adhesion, this outcome was not reported in the finalresults. Although the patients’ ages ranged between 8 months and 80 yearsand the size of the donor site dressings between 8 to 800 cm2, the authors didnot make reference to how these variables affected the results obtained.Moshakis, Fordyce, Griffiths, McKinna (1 984) conducted a randomizedcomparative study using MVPD and gauze dressings in patients who hadundergone breast surgery. A total of 120 patients took part in the study, 61patients 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 not24described. This study evaluated both the patients’ and the nurses’ perceptions.Patients using the MVPD reported a higher degree of satisfaction with theirdressings than patients using gauze dressings. Nursing staff stated that MVPDwere easy to apply but once again reported that leakage around the dressingwas a problem.Shell et al, (1986) conducted a randomized pilot study comparing MVPDand lanolin gauze dressings in terms of their capacity to promote healing andensure comfort in patients with open skin lesions secondary to RT. Sixteenpatients were included in the study. Eight were randomized to receive theMVPD and eight to receive the lanolin dressing. Healing time was measured indays from lesion onset to the complete reepithelialization of the lesion. Theaverage 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. Shellattempted to explore the concept of discomfort but found it difficult to quantifydue to the changing nature of the lesions. Overall, the results of this studywere similar to previous studies and documented that MVPD can be usedduring RT without creating an undesirable dispersement of radiation to the skin,referred to as a bolus effect.Gentian VioletGentian Violet, (methylrosaniline chloride 1 %), is one of the currentproducts 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 irradiated25area. GV acts as a topical antifungal and antibacterial agent (Berner &Rotenberg, 1990). It has been utilized for years for open skin lesionssecondary 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. Theconstant shedding of the corneum of the skin creates a dry unfavourablehabitat which prevents invasion of these pathogenic organisms (Wood &Blada,1 985). The application of GV on the injured epidermis maintains this dryhabitat, and thereby inhibits bacterial and fungal invasion (Springhouse, 1991).No studies evaluating the pharmacological properties of GV in relationship toRISR have been completed to date. A study including 19 patients whodeveloped an open skin lesion following RT for early breast cancer is currentlybeing conducted by Dr. D. Pickering (personal communication, June 24, 1993)at Pembery Hospital in Kent, England. The study uses a comparative designinvolving GV and a hydrogel dressing called “2nd Skin”-J-M. The study evaluatesthe effectiveness of the two treatments in relation to the level of discomfortand irritation of the skin at the lesion site, as well as restriction of armmovements and sleep disturbances. The details of the study methods,measurement tools, and the final results are not available. The preliminaryfindings, however, appear to show that healing time is reduced and thatpatients express a higher degree of satisfaction with the moist method of26promoting healing.Summary of the Literature ReviewAlthough skin reactions secondary to RT occur less frequently since theintroduction of megavoltage RT equipment they still are identified by patientsreceiving 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 techniquesfor RISR, but very few are based on systematic evaluations of theireffectiveness. Two products currently used in the care of open skin lesionssecondary to RT are; GV and MVPD. No studies to date were found thatevaluated the effectiveness of GV in the treatment of any form of tissue lostinjuries including RISR. Studies were found that evaluated the use of MVPD intissue lost injuries including RISR. Caution must be used in drawing anydefinite conclusion regarding the few studies that have been done to date.Most of the studies to date used non-comparative designs, had crude methodsto assess the study outcomes, and did not control for important factors suchas the size of the lesion and patient’s age. Shell’s et al, (1986) pilot studyundertook the scientific evaluation of MVPD in the care of open skin lesionssecondary to RT, but because of the small sample size, no clear conclusioncould be drawn. Further studies are needed to evaluate the effectiveness ofthe various treatments used in the care of RISR, particularly the treatments ofGV and MVPD.27CHAPTER 3MethodsIntroductionIn this chapter the research design, sample selection criteria, proceduresused for data collection and data analysis as well as the means used for theprotection of human rights will be described.Research DesignThis study used an experimental, randomized controlled design (Figure II).All patients who met the selection criteria and agreed to participate in the studywere randomly assigned, using a table of random numbers, to receive either GVor MVPD skin care protocol (Appendices C & D). The indicators used tomeasure the study outcomes included: the number and size of the open skinlesions; characteristics and size of erythema; amount and characteristics ofexudate; grade of healing; and the level of discomfort at the lesion site. Thestudy ended when the lesion healed. All of the observations and procedureswere carried out by the investigator.Selection CriteriaPatients were included in the study provided they met the followingcriteria:1. Aged between 18 and 70 years.2. Diagnosed with head and neck cancer.28Figure II. Design of the StudyE1 Op1 Op2 Op3 Qpfl/O ROp1 Op2 Op3 OpLegend:= Identification of potential participants.QX= Occurrence of an open skin lesion.Personal and medical histories as wellas baseline assessments of thefollowing study outcomes areperformed: (1) size of the open lesions;(2) size and characteristics of theerythema;(3) amount andcharacteristics of the exudate; (4)cultures and photographs; (5) grade ofhealing; and (6) level of discomfort atthe lesion site.R = Random assignment to one of the studygroups.E1 = Experimental group, MVPD.E2 = Control group, GV.Op1 to Op = Assessment of the skin condition(number 1 ,2,3,5 above) and level ofdiscomfort are done 2 to 3 times perweek. Cultures and photographs of thelesion are taken approximately everyseven days.Op = Lesion healed, end of study.293. Scheduled to receive a total dose of 4,000 cGy or greater ofexternal radiation fractionized daily.4. Had developed an open skin lesion secondary to RTwithin 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 fieldarea.2. An open lesion at the start of RT.3. Clinical and microbiological signs of an acuteinfection 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 CollectionTwo forms, the Personal and Medical Histories form (Appendix E) and theAssessment Flow Sheet (Appendix B), were designed for the study based onthe literature and other instruments used to record to the skin response toradiation and the healing process (Bloomer & Hellman, 1975; Cunon, 1985;Malkinson & Keane, 1 981; Overgaard et aI, 1987; Sitton, 1992; Wang, 1991;30Yasko, 1983).The Personal and Medical History Form was used to record: (1) basicdemographic data (age, gender, language, and place of residence); (2) medicalhistory (history of RT or surgery in the RT field, current medications, history ofdiabetes, peripheral vascular disease, allergies, skin cancer or acne); (3)radiation therapy plan parameters (RT site and field size, dose received, numberof fractions) and (4) skin care routine.The Assessment Flow Sheet was used to document: (1) size and numberof lesions; (2) size and characteristics of the erythema; (3) amount andcharacteristics of the exudate; (4) grade of healing; (5) the level of discomfortat the lesion site; and (6) side effects associated with the study treatments.The size of each lesion was measured using a flexible grid designed bySmith and Nephew (Appendix A). The grid was placed on top of the lesion andthe edges of the lesion were traced with a marker pen. The surface wascalculated in cm2 by counting the number of squares within the traced area andthen adding these scores together to form one score.The grade of healing of the lesion was determined by matching theamount of reepithelialization present in each lesion to the followingclassification: Grade 1, none; Grade 2, spotty small areas; Grade 3, centrallylarger areas; Grade 4, complete healing (Appendix F) (Cunon, 1985). Thisclassification is based on the fact that healing is a gradual process that can beevaluated by observing the amount of reepithelialization; reepithelialization31being defined as the replacement of lost tissue with tissue of the same orsimilar type. This process ends with the complete healing of the lesion.The size of the erythema was determined using the same proceduredescribed for the measurement of the lesion size. The characteristics of theerythema were assessed by matching the colour of the skin to the colourgroupings presented in Appendix G. In the literature the characteristics oferythema are usually described as faint, bright or deep hues of red with noother further clarification (Malkinson & Keane, 1 981). To improve the accuracyof the evaluation, specific colour groupings were developed for this study andwere validated with BCCA professional staff prior to their use by asking themif they agreed with the colour grouping selected for this study to describeerythema . If the erythema reflected more than one colour grouping then thecolour grouping that occupied more than 50% of the total area was selected.Part of this study was to measure and evaluate the amount of exudatefrom the lesions by tracing for the MVPD group, the pockets of fluidaccumulated under the dressing and for the GV group, the amount of crustingpresent, using the same procedure previously described for the determinationof the lesion size. However, it was not possible to make an accuratemeasurement using this method for the following reasons: (1) the exudate didnot accumulate under the MVPD to form pockets in all patients; (2) a largeamount 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 from32one assessment visit to the next as well as the total accumulated exudate fromthe beginning of the lesion onset. Therefore, this outcome indicator was notassessed in this study.The characteristics of the exudate were evaluated according to thefollowing 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/ortenderness experienced by patients at the lesion site. These components werechosen based on various studies describing the patient’s experience with RT(Barnet et al, 1 983; Bloomer & Hellman, 1975; James & Watcon, 1 975; Kinget al, 1985; Malkinson & Keane, 1981; Pickering, 1993; Shell et al, 1986;Sitton, 1992; Wang, 1991). Each component of discomfort was assessedusing a visual analog scale (VAS). The VAS is easy to administer and score(Jeasen, Karoly & Brauer, 1986) and has been shown to be reliable andsensitive to pain intensity variations (McCaffery, 1989; Seymour, 1982). TheVAS used in this study consisted of a 10 cm single horizontal line with theanchor words of none and excruciating at each end. Patients used a moveablemarker to indicate a point on the line which best reflected their level ofdiscomfort. A score was obtained by measuring in cm the distance from thefirst anchor word to the mark.33Pre-testAll the instruments and procedures used in this study were pre-tested on5 patients with head and neck cancer for one to two day period during theinitial formation of a lesion. During this time period the problems identified inrelationship to measuring the amount of exudate was not apparent due to thebrief time frame selected for the pre-testing period. Lesions during the timeperiod had either scant or no exudate present. The pre-testing did indicate thatthe VAS was easily understood by patients and the components selected todescribe discomfort clearly reflected the quality of the patient’s painexperience. No revisions were necessary.ProceduresPatients included in this study were recruited from the Radiation TherapyDepartment at the British Columbia Cancer Agency, Vancouver Clinic. Allpatients had either completed or were near completion of a 4 to 5 week RTtreatment plan. The Radiation Oncologists responsible for the primary medicalcare identified potential study participants and obtained their permission to beapproached by the investigator. If patients were interested in taking part in thestudy, a meeting took place to explain the study and obtain their consent(Appendix I).Initially, a baseline assessment was done that included the collection ofpersonal and medical history information. When an open lesion first appeared,the following data were collected; number and size of the lesions, size and34characteristics of the erythema, amount and characteristics of the exudate,grade of healing, and level of discomfort at the lesion site. These parameterswere assessed two to three times per week until the lesions healed. Baselinecultures were performed to determine that the lesion was free of an acuteinfection prior to starting the study. Cultures of the lesions were repeatedevery seven days until the lesion healed. These were done following theprocedure outlined in Appendix J and microbiological evaluations wereperformed by the microbiology department at BCCA, Vancouver Clinic. Theresults were reported to the primary physician and the investigator. If purulentexudate was observed, additional cultures were taken.After the baseline data was collected patients were randomized to eitherthe GV or the MVPD skin care treatment groups and were oriented to the skincare protocols (Appendices C & D). The investigator performed the skin careprocedures initially and at each subsequent visit and the patient or care providerdid it at other times. The MVPD (Op-Site), GV and sterile dressings supplieswere provided free of charge by Smith and Nephew and BCCA.Patients were seen at least 2 to 3 times a week either in the BCCAVancouver Clinic’s Radiation Day Care or at their home to evaluate the studyoutcomes and assess the difficulties or problems the patients had with thestudy treatments. The frequency of the visits varied depending on the need forassistance and/or for dressing changes and patient’s availability to come to theclinic.35Photographs of the lesion were taken at the time of lesion onset andrepeated every seven days until the lesions healed to provide a pictorial recordof the lesion status throughout the study. These photographs of the lesionswere done by the investigator following the procedure outlined in Appendix K.Due to a technical problem with the camera equipment the quality of thephotographs were not adequate for evaluation and therefore will not beincluded in this thesis.Data Analysis ProceduresData from the coded Personal and Medical History Forms and theAssessment Flow Sheets were computerized using the Statistical Program forthe Social Sciences (SPSSX). General characteristics of the sample in terms of(1) soclo-demographics (age, gender, language, place of residence); (2) RTtreatment plan parameters (treatment site and field size, dose received, numberof fractions); (3) skin condition (size and characteristics of the erythema,number and size of the lesions [the size of the lesion was always reported asthe total area of all of a patient’s lesions], characteristics of the exudate andgrade of healing); and (4) level of discomfort were described using basicdescriptive statistics (frequency, range, mean).Prior to testing the hypotheses, the equivalence of the study groups atthe onset of the lesion was assessed. Equivalence was determined bycomparing age, RT treatment plan parameters, skin condition and level ofdiscomfort, using the Mann-Whitney U-test. The level of significance was set36at.p = 0.05 (Conover, 1980; Pagano, 1981).The first hypothesis related to the rate of healing was assessed bytesting the differences between the two study groups in terms of: (1) thenumber of days from lesion onset to complete healing to evaluate the overallhealing rate; (2) the number of days from maximum lesion size to completehealing to verify the effectiveness of the study treatments when the largestamount of tissue damage was present and (3) the number of days from grade1 to 2; grade 2 to 3; and from grade 3 to 4 to assess the impact of the studytreatments on the various phases of the healing process.The second hypothesis related to the level of discomfort experienced bypatients at the lesion site was tested by looking at the differences between thestudy groups for each of the components of discomfort (burning, itchiness,pulling and tenderness) at two points; 24 hours after beginning the studytreatment and when the lesion was at its maximum size. The latter evaluationwas chosen based on the assumption that a larger lesion would produce morediscomfort than a smaller lesion. All testings were performed using the MannWhitney U-test, with a level of significance set at 0.05.AssumDtionsThe following assumptions guided the study:1. Patient’s receiving RT for their cancer are interested inparticipating in the study.2. Patients are able to follow the skin care protocols adequately once37they have been taught.3. A larger lesion will produce more discomfort than a smaller lesion.LimitationsThe following limitations were identified in the study:1. The small convenience sample of patients restricts thegeneralization 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 RightsThis proposal was approved by the Clinical Ethics Committee of theUniversity of British Columbia, the BCCA Nursing Division Research Committeeand the Radiation Oncologists who provided care to the head and neck cancerpatients. Patients were informed of the purpose and procedures of the studyas well as the benefits and inconveniences that may occur during the study.Patients were informed that their participation was voluntary and their refusalor withdrawal from the study would not affect in any way their treatment orcare 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 wasgiven to the patient. Patient’s names were never used and confidentiality wasmaintained by using a code number on all documents.38The procedures used in this study are acceptable skin care treatments forRISR in cancer centres. To ensure their protection, patients were removed fromthe study when side effects to the study treatments such as an allergicreactions or infection occurred.Summary of the MethodsThis chapter has presented the methods used in this study: the design;sample selection criteria; procedures for data collection and data analysis; andthe measures used to protect the patient’s rights.39CHAPTER 4Presentation and Discussion of the ResultsIntroductionThis chapter consists of three sections. The first section presents thecharacteristics of the sample and the equivalence of the study groups in relationto: (1) socio-demographic characteristics; (2) medical history and RTparameters; (3) skin condition; and (4) discomfort level at the lesion site. Thesecond section reports the findings related to the two hypotheses. Finally, thelast section discusses the results of the study.General Characteristics of the SamDleThirteen patients were enroled in this study. Of these, 6 patients wereassigned to the MVPD group and 7 to the GV group. Four patients did notcomplete the study (1 in the MVPD group and 3 in the GV group) for thefollowing reasons: allergic reaction to the adhesive product used in the MVPD(#10); severe burning (#11, #12) related to the GV treatment; andinconvenience of GV (#13) which was found to be too messy. All 4 patientswithdrew from the study within 48 hours and therefore will not be included inthe analysis.Socio-demoqraphic CharacteristicsFive patients had English as their primary language, 3 had Cantonese and1 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:4051 to 64 years) and 53.6 years (Range: 41 to 70 years) for the GVgroup and MVPD group respectively. There was no significant differencebetween the two groups in terms of age.Medical and Radiation Therapy CharacteristicsMedical and RT data to be reported included: (1) tumour site, history ofhead 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 neckmalignancies, most often cancers of the nasopharynx and of the tongue (Table3). None of the patients had received radiation or chemotherapy prior to studyor had a history of skin cancer, allergies or acne. Three patients, 2 in the GVgroup and 1 in the MVPD group, reported having other medical conditionsincluding diabetes (#6), peripheral vascular disease (#6,#2,#8) and one hadprevious head and neck surgery (#6).Overall the RT lasted, on average, 38.7 days (Range: 34 to 43 days), 38days and 39.6 days for the GV and MVPD groups, respectively. Patientsreceived 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: 4,000to 6,000). The average RT field size was 400.4 cm2 (Range: 60.5 cm2 to 780cm2), with a mean of 303.1 for the GV group (Range: 120 to 420 cm2) and ofTable3Demociranhic.RadiationTheraDvandMedicalCharacteristicsoftheSamDlePatientGenderAgeTumourRadiationTherapySiteDoseFractionsDurationFieldSizecm2GVGrounM64VocalCord6,0002536120.03*M51Nasopharynx4,5002043392.5M62Submandibular6,0002536420.07*M62PyriformSinus6,0002537280.011M45Tongue6,0002536562.012M43Tongue6,0002538584.013M62Nasopharynx4,5002043420.0M55.65,57123.838.4396.959.85,62623.638.0303.1MVPDGroup1*M70VocalCord6,000253661.04*M44Nasopharynx4,5002047780.05*F53Nasopharynx4,0002045303.5M60Pharynx6,0002534336.09*F41Tongue5,7602436538.010M72PyriformSinus6,0002536276.0M56.75,37723.139382.453.65,25222.839.6403.7TotalM56.15,43923.438.7400.4TotalM*56.75,43823.238.8353.4,patientswhocompletedstudy,a,diabetes;b,peripheralvasculardisease,Q=O.O5H42403.7 cm2 for the MVPD group (Range: 61 to 780 cm2) (Table 3). Thenumber of RT fractions ranged from 20 to 25, (M = 23.6), with themean of 23.6 for the GV group and 23.1 for the MVPD group. Fourpatients, 2 in the GV group and 2 in the MVPD group, had their RTinterrupted for 7 consecutive days because of scheduling difficulties. Nointerruptions were related to adverse reactions to the RT. There were nosignificant differences between the two groups in relationship to any ofthe above RT parameters.In terms of skin care to the area, all patients used only tap waterto cleanse the skin within the therapy field area. Cornstarch andhydrocortisone cream 1 % were used to control itchiness prior to thedevelopment of lesions in 4 patients, 2 in the GV group and 2 in theMVPD group, but all had stopped the use of these products prior toentering the study. One patient was using cologne daily, but stoppedprior to the start of RT.Skin Condition at Lesion Onset and at Maximum Lesion SizeThe equivalence of the study groups at the beginning of the studyis presented in terms of date of occurrence of the lesion in relation toRT, number and size of lesions, size and characteristics of erythema,characteristics of exudate, microbiological results, grade of healing andlevel of discomfort at the lesion site.The lesions first occurred between 40 and 47 days (M = 44.943days) after beginning RT. Two of the 9 patients developed their lesionsprior to completing RT and 7 after their RT ended. At the time of lesiononset, patients had, on average, 2.5 lesions (range of 2 to 4) whichcomprised a total surface area of 20.1 cm2 (Range: 1.5 to 46 cm2)(Table4). A deep purple erythema was observed in 55% of the patients andthe remaining had a bright erythema. The mean size of the erythemawas 200 cm2 (Range: 45 to 384 cm2). The majority of lesions (n =6)had serous-sanguineous exudate, 2 had serous exudate, one had noexudate and all were free of microbiological infections. None of thelesions showed evidence of reepithelialization.The lesions reached their maximum size 44.9 days after thebeginning of RT. On average, patients had 2 lesions with a mean sizeof 160.5 cm2 (Range: 1.5 to 408 cm2). A deep purple erythema wasobserved in 67% of patients and the remaining had a bright erythema(Table 5). The size of the erythema was at this time 201.3 cm2. Alllesions except one (#8) had serous-sanguineous exudate and none hadevidence of microbiological infection.Discomfort Level at Lesion OnsetLevels of discomfort varied from 2 to 9 for burning (M = 5.8);from 0 to 10 for itchiness (M = 5.8); from 5 to 8 for pulling (M = 6.3);and from 3 to 10 for tenderness (M= 6.7) (Table 6).Table4SkinLesionsCharacteristicsatOnsetandMaximumLesionSizePatientDaysFromBeginningRT#ofLesionsSize(cm2)atOnsetatMaximumSizeatOnsetatMaximumSizeatOnsetatMaximumSizeGVGroup39422119.0056.0339504204.4152.036453107.6400.0742432246.0056.0Mwithout#640452.71.723.1088.0M39453.81.519.3166.0MVPDGroup146461101.5001.5441471112.3408.0547492214.0243.08b43442223.0077.0938383335.0035.0M4344.82.71.817.2154.9M4144.93.31.718.3160.5Mwithout#641.544.92.71.820.1121.5adiabetesb,peripheralvasculardisease12=0.05Note.Sizeoflesionisthesumoftheareasofallofthepatient’slesions.Table5ErvthemaandExudateCharacteristicsatLesionOnsetandMaximumLesionSizePatientErythemaExudateatOnsetatMaximumSizeatOnsetatMaximumSizeColourSizeColourSizeGVGroup2bDP200.0DP200.0SSSS3DP384.0DP152.0SSSS6a,bDP360.0DP420.0SSSS7BR124.0DP124.0SRSSM256.9*224.0MVPDGroup1BR045.0BR045.0SSSS4DP180.0DP408.0NONESS5DP200.0DP200.0SSSS8bBR060.0BR060.0SRSR9BR180.0BR180.0SSSSM164.2178.6TotaiM210.6121.3a,diabeticbperipheralvasculardiseaseBR,brighterythemaDP,deeppurpleerythemaSR,serousexudateSS,serous-sanguineousexudate*=0.0501Table6LevelofDiscomfortatThreeTimePeriodsPatientOnset24HoursMaximumLesionSizeBIPTBIPTBIPTGVGroup2b83553386838638107101010710687862459449865987366566667666M5.*1.4*0.8*3.8*0.8*0.8*0.8*2.2*TotalM5.,diabeticb,peripheralvasculardiseaseNote.B,burning(0to10)I,itchiness(0to10)P.pulling(0to10)T,tenderness(0to10)*R<0.00147Equivalence of the GroursThere were no significant differences between the two studygroups in terms of: (1) lesion onset in relation to the beginning of RT (GVgroup: M= 45 days; MVPD group: M= 43 days); (2) size of the lesionat onset (GV group: M 19.3 cm2; MVPD group: M 17.2 cm2); (3)the lesion at maximum size (GV group: M= 166.0 cm2; MVPD group: M= 1 52.9 cm2); (4) size of erythema at maximum lesion size (GV group:M = 224 cm2; MVPD group: M= 178.6 cm2); and (5) level ofdiscomfort at the lesion site at the beginning of the study (Table 6).In conclusion, the two study groups were equivalent in relation tothe above parameters with the exception of the size of erythema atlesion onset (GV group: M= 267 cm2, Range: 124 to 384 cm2 andMVPD group: M= 133 cm2, Range: 45 to 200 cm2). The GV group hada significantly larger area than did the MVPD group (jj 9, = 0.05),but this difference was not seen when the lesions were at theirmaximum lesion size.Hypothesis One Regarding Rate of HealingThe first hypothesis tested was that open skin lesions secondaryto radiation treated with MVPD will heal faster than lesions treated withGV. The 4 patients who did not complete the study were excludedfrom the analysis. Also, because the healing process may have beenaffected by factors such as diabetes and surgery, analysis was done48excluding patient #6 who had both of these conditions.The number of days from lesion onset to complete healing variedfrom 5 to 46 days (M= 18.5). Healing time for the GV group, was 1 5to 46 days (M = 25) and for the MVPD group 5 to 26 days (M = 12).There was a significant difference between the two groups. The lesionstreated with MVPD healed at faster rate than those treated with GV (U8, p = 0.05) (Table 7). The MVPD group had healing rates as lowas 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 of13.8 days were required for complete healing (Range: 5 to 35). For theGV group, the average was 21 days (Range: 14 to 35) and for theMVPD group it was 6.6 days (Range: 6 to 20) (Table 7). There was asignificant difference between the two groups ( = 8, = 0.05) (Table7).There were differences between the two groups during phases ofthe 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 forthe MVPD group were: grade 1 to 2, 3.8 days; grade 2 to 3, 3.4 days;49Table 7Healing Rates From Lesion Onset and Maximum Lesion Size to ComQleteHealingPatient From Onset From Maximum SizeGV Groun15.0 14.03 46.0 35.06’ 80.0 71.07 15.0 14.039.0 33.525.0 21.0MM without # 6MVPD Group1 06.0 06.04 26.0 20.05 13.0 11.08b 10.0 09.09 05.0 05.0M 12.0* 06.6*25.5 20.118.5 13.8Total MTotal M without # 6a diabetesb, peripheral vascular disease* R = 0.05and grade 3 to 4, 5.6 days. The differences were statistically significantfrom grade 2 to 3 (spotty sparse areas of reepithelialization to centrallarger areas of reepithelialization) ( = 8, = 0.05) (Table 8).Hypothesis Two Related to Discomfort Levels at the 0en Lesion SiteThe second hypothesis tested was that patients using MVPD will50experience less discomfort at the lesion site than patients receiving GV.On the day the lesions occurred, the mean VAS scores for both groupswere above the scale midpoint for each of the sensations (burning M=5.8; itchiness M= 5.8; pulling M= 6.3 and tenderness M= 67) (Table6).Patients, on the MVPD treatment had their level of burningdecreased from a mean of 6.4 to of 1 .4 after receiving the treatment for24 hours. A further decrease was also noted when the lesions were atmaximum size (M = 0.8). On the other hand, patients on the GVexperienced burning sensations which increased when the lesions wereat maximum size (M= 5.3 at lesion onset, M = 5.8 after 24 hours andM= 6.8 at maximum lesion) (Table 6 and Figure IV).Itchiness decreased from a mean of 5.8 to 1 .4 after being on theMVPD for 24 hours and a further decrease was seen when the lesionswere at maximum size (M = 0.8). Itchiness levels remained constant forthe patients that received the GV treatment (M = 5.8 at onset, M= 5.824 hours after beginning the treatment and 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 onMVPD and as was the case for, the other sensations, further decreasewas seen when the lesion was at maximum size (M = 0.8). Pullinglevels were increased after the patients received the GV treatment and51remained 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 andM 7.5 at lesion maximum) (Table 6 and Figure VI).Table 8Duration of Healing in Days in Terms of Grade of HealingPatient Grade Grade Gradelto2 2to3 3to4GV2b 4 8 33 4 10 326a,b 12 19 497 2 8 5M 5.5 11.3 22.3Mwithout#6 3.3 8.7 13.3MVPD1 2 2 24 9 7 105 4 6 48” 2 1 89 2 1 4M 3.8 34* 5.6M 4.7 7.4 14.0Mwithout#6 3.6 6.1 9.5a diabetesb, peripheral vascular disease*— 0.05Note.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.52Figure III. Level of burning at lesion onset, 24 hours on study and whenlesion was at maximum size.6.75765432I0to0ci)ci)• Lesion Onset•24 hours on study•When Lesion At Maximum SizeNote. 0 to 10, none to excruciating53Finally, the levels of tenderness were also reduced with the MVPDtreatment 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 otherhand, did not experience any improvement in their level of tenderness (M= 7.3 at lesion onset, M= 7.5 24 hours beginning the treatment andM= 7.0 at lesion maximum) (Table 6 and Figure VII).There were significant differences between the two groups at 24hours after beginning the treatment and when the lesions were at theirmaximum size for each discomfort sensation (U = 8, R < 0.001) (Table6).Besides the allergy to the adhesive product used in the MVPD andthe severe burning already mentioned in the section entitled “GeneralCharacteristics of the Sample”, no other side effects to the studytreatments were noted.DiscussionIn this section, the findings of this study will be discussed inrelation to the theoretical framework and the literature as well as themain methodological procedures.54Figure IV. Level of itchiness at lesion onset, 24 hours on study andwhen lesion was at maximum size.Cl)C,)0C-)4)C0-i11)0•Lesion Onset•24 hours on Study• When Lesion at Maximum SizeTotal Sample Gentian MVPD GroupViolet GroupNote. 0 to 10, none to excruciating55Figure V. Level of pulling at lesion onset, 24 hours on study and whenlesion was at maximum size.88765•r-1z0G)n•Onset of Lesion•24 hours on Study•When Lesion at Maximum SizeTotal Sample Gentian MVPD GroupViolet GroupNote. 0 to 10, none to excruciating56Figure VI. Level of tenderness at lesion onset, 24 hours on study andwhen lesion was at maximum size.876543Cl)G)ci)Vci)E-02ci)ci) I• Onset of Lesion•24 hours on Study•When Lesion at Maximum SizeTotal Sample Gentian MVPD GroupViolet GroupNote. 0 to 10, none to excruciating57Findings Related to the HypothesesFirst HypothesisThe results of this study confirm that: (1) the open skin lesionstreated with MVPD healed significantly faster than lesions treated withGV as indicated by the healing rates from lesion onset to completehealing and from maximum lesion size to complete healing; (2) thehealing rate of lesions treated with MVPD was faster once the processof reepithelialization had been initiated and significantly faster betweengrade 2 and 3.The findings in this study are consistent with those reported inother studies evaluating the use of moist healing methods in the care ofopen skin lesions secondary to RT (Dini et al, 1 993; Margolin et al,1990; Shell et al, 1 986). Furthermore, they strongly suggest that MVPDhas properties that facilitate the healing process.Radiation damages the DNA structure of the cells of the skin(Bloomer & Hellman, 1975). This cell damage can results in theformation of an open skin lesion. Once a lesion is formedreepithelialization 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 asprotecting the lesions against contamination, friction or trauma,maintaining a clean moist environment and ensuring adequate oxygen,58nutrition and fluid levels. MVPD provides a clean moist protective barrierthat facilitates cell migration. MVPD, also encourages the free passageof oxygen into the lesion which promotes the healing process.In this study, differences were seen between the two groups inrelation to the overall healing rates. In addition the study resultsindicated that MVPD is most effective once the reepithelializationprocess was most active; that is when the lesion moved from grade 2to grade 3 and from grade 3 to grade 4. These differences werestatistically significant in relationship to the time it took for the lesion toprogress from grade 2 to 3.Second HypothesisThe results of this study confirmed that the level of discomfortwas significantly lower in patients treated with MVPD. It was clearlyevident from these results that the intensity, for all four sensations,changed dramatically in the MVPD group once the treatment wasinitiated. Patients receiving the GV treatment did not experience anyimprovement in their sensations; discomfort was, in some instances,even enhanced. In fact, 2 patients in GV group with lesions greater than100 cm2 had twice as much discomfort (VAS scores of 5 and 9) than 2patients having similar lesions treated with MVPD (VAS scores of 0 and2). The reasons for the differences probably relates to the properties ofMVPD and GV. MVPD creates a moist environment that prevents the59skin from puckering around the open lesion site and provides a constantprotective barrier to the abraded nerve endings. GV on the other hand,because of its drying properties, increases the puckering around thelesion as well as creating a scab that frequently cracks.The following results, although not directly related to thishypothesis provide valuable clinical information. For the majority ofpatients, the lesions developed after completing their RT. This findingis consistent with the literature describing the effects of RT on thecellular structure and normal physiological processes of the skin. Skincells on average have a mitotic rate of 14 to 21 days, but this isshortened during the healing process (Dagher, 1985). Radiation affectsthe mitotic rate by destroying the DNA structure of skin cells (Bloomer& Hellman, 1975; Malkinson & Keane, 1981) and this effect persists forat least 7 to 21 days following RT (Frogge, 1982). Thus, the skindamage secondary to RT can occur well beyond the period of activetreatment.It was also noted that the dose of radiation received, patients witha treatment field size greater than 300 cm2 developed lesions greaterthan 100 cm2 and patients whose treatment field size was less than 300cm2 developed lesions smaller than 100 cm2. These observations, leadthis investigator to think that the size of the treatment field is one of themajor factors in the determination of lesion size.60Methodological ConsiderationsIn this section, the findings of the study are discussed in terms ofthe representativeness and equivalence of the sample and methods usedto evaluate the study outcomes.Representativeness of the SampleHead and neck cancer is 2 or 3 times more prevalent in males thanfemales (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 theadministration of 4,000 cGy to 7,000 cGy of radiation given in 20 to 30fractions. In this study, 9 patients, 7 males and 2 females, with a meanage was 56.7 yearswere enroled. During the course of their 39 days ofRT, 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 lowerthan the B.C. provincial statistics (BCCA, 1991), these figures indicatethat the study group shared similar demographic characteristics and RTplan parameters with the B.C. head and neck cancer population (BCCA,1992).Equivalence of the Study GroupsThe equivalence was assessed by comparing the two study groupsin terms of: age; RT plan parameters; skin condition at lesion onset; and61level of discomfort at lesion onset. The GV and MVPD groups wereequivalent in terms of all the above variables except for the size of theerythema at the time of lesion onset (M 267 cm2 for the GV group andM= 133 cm2 for the MVPD group). The reasons for this difference inthe erythema size is unknown but could be related to the small samplesize. However, it is known that the size of the erythema is related to thesize 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 differencesexisted between the two groups in terms of these RT parameters at thetime of lesion onset and when the lesions were at their maximum size.The results of these comparative analyses indicated that the two studygroups were comparable.In conclusion, the two study groups were equivalent in terms ofmost of the important demographic and clinical factors.Evaluation of the Study OutcomesThe size of the lesion and erythema were measured with the Smithand Nephew flexible grid described in Chapter 3. Although, thisprocedure provided an accurate evaluation of these outcomes it was timeconsuming and led to some difficulties in distinguishing the exactmargins of the lesion, especially when reepithelialization started at thelesion rim; a problem that was also noted by Bryant (1992). It is62therefore suggested that a simpler method such as the sum of the twolargest perpendicular axis be used as a measurement method in futurestudies.The lesion size and grade of healing were evaluated at least 2 to3 times a week using the procedures described in Chapter 3 under thesubheading titled “Data Collection Instruments”. The investigator foundthat these evaluation time periods were sufficient to provide a goodestimation of the number of days it took for each of the lesions to movefrom one grade to the next grade. If an absolute precise determinationwas 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 colourgrouping described in Chapter 3. Although GV may interfere with theevaluation of the colour of the erythema, this problem was overcome byevaluating the skin around the open. lesion.Discomfort, defined as a burning, itchiness, pulling or tendernessexperienced by patients at the lesion site, was measured with the VAS.Published papers indicated that VAS may be difficult to use especiallywith older patients (Jensen, Karoly & Braver, 1986; Joyce, Zutchi,Hrubes & Mason, 1975). In this study, the majority of patients were notfamiliar with the VAS and required some explanation. Following theexplanation, all understood how to use the instrument and had no63difficulty in reporting their discomfort.The characteristics of exudate were assessed using a scale basedon the literature regarding RISR (see Chapter 3). A milky yellowishexudate which was not included in the scale used in this study, wasnoted in all lesions at some time during the healing process. Bryant(1992), mentions that this type of exudate, is normal in the healingprocess. Further studies are needed to assess exudate from RISR.The conceptual framework underlying this study, the healingprocess and the factors that either enhance or impede this process,guided the evaluation of the study results in terms of factors to considerwhen evaluating the equivalence of the two groups and the healing ratesof the two groups. The framework identifies that skin closure primarilytakes place by cell migration across the lesion bed. The principlesunderlying the effectiveness of the MVPD indicated this was therationale for the faster healing rates seen in this study. The conceptualframework indicates that factors such as the excessive dryness of thelesion bed could impede the healing process, therefore the dryenvironment created by the GV probably interfered with thereepithelialization of the tissue, slowing the healing process.SummaryThe characteristics of the sample, the findings related to the twohypotheses, methodological considerations and discussion of the results64have been presented in this chapter in relation to the theoreticalframework and other research studies.The sample was comprised of 9 subjects between the ages of 41and 70 years. The sample is representative of head and neck cancerpatients in the province of B.C.. The equivalence of the two studygroups in terms of: age; RT plan parameters; skin condition; anddiscomfort levels at the lesion site was determined prior to testing thehypotheses. The healing rate of the lesions were analyzed from the dayof onset to complete lesion healing as well as from when the lesionswere at their maximum size until complete healing. Level of discomfort,described as a burning, itchiness, pulling or tenderness sensations at thelesion site, were analyzed at two time periods during the study (24 hoursafter the start of the study treatment and when the lesions were at theirmaximum size).The two study groups were equivalent with the exception of sizeof erythema at lesion onset. The results of this study confirm that: (1)the open skin lesions treated with MVPD healed significantly faster thanlesions treated with GV as indicated by the healing rates from lesionsonset to complete healing and from maximum lesion size to completehealing; (2) the healing rate of lesions treated with MVPD was fasteronce the process of reepithelialization has been initiated; and (3) thelevel of discomfort was significantly lower in patients treated with MVPD6524 hours after beginning the treatments and when the lesions were attheir maximum size. The results of the study were generally consistentwith the limited published papers on the subject.66CHAPTER FIVESummary, Conclusions, Implications and RecommendationsIntroductionThis study was designed to examine and compare theeffectiveness of GV and MVPD in promoting healing of an open skinlesion and reducing the level of discomfort at the lesion site. Anoverview of the study is presented in this chapter followed byconclusions, implications for nursing practice, and recommendations forfuture research.SummaryA review of the literature revealed that various methods are usedfor the care of open lesions secondary to RT. However, only two studieswere found addressing the healing rate and level of discomfort inrelationship to specific skin care methods (Margolin et al, 1 990; Shell etal, 1986).This randomized controlled study was conducted with aconvenience sample of 9 patients with head and neck cancer currentlyreceiving RT as a primary treatment were included in this study. Patientswere enro led into the study at the onset of an open skin lesion and wererandomized to either the GV or MVPD skin care study groups. The agerange of the patients was 41 to 70 years (M = 53.6). The groups were67equivalent in terms of age, RT plan parameters, skin condition and levelof 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 treatedwith MVPD demonstrated a significantly faster healing rate than didthose treated with GV at two points during the study: (1) from lesiononset to complete healing; and (2) from maximum lesion size tocomplete healing. The results also indicated that the rapidity of thehealing rate observed in the MVPD group occurred during the phases ofthe healing process when reepithelialization was the most active.The patients treated with MVPD experienced significantly lowerlevels of burning, itchiness, pulling and tenderness at the lesion site 24hours after starting the study treatment and when their lesions were atmaximum size than the patients treated with GV.The reasons underlying the discomfort results seem to be relatedto the two different modes of action associated with the products; moistversus dry. The clean moist healing environment created by the MVPDsignificantly reduced the patients levels of discomfort, whereas the dryenvironment created by the GV did little to reduce the patient’s level ofdiscomfort and at times even enhanced it.Neither of the two skin care treatments appeared to have an effecton limiting the extent of the lesion. The damaging effects of the RT on68the skin occurred regardless of the two study treatments. In addition,the results indicated that one of the main considerations related to thesize of the lesions appeared to be the size of the RT field rather than thedose of radiation received, when the total dose of radiation exceeded4,000 cGy.ConclusionsDue to the convenience method of sampling and the small samplesize, the results of this study cannot be generalized. However, thefindings of this study suggest a faster healing rate and lower levels ofdiscomfort are associated with moist healing methods rather than dry.ImplicationsThe findings of this study provide important implications fornursing practice, education and theory. First, the study results suggestthat skin reactions secondary to RT are a major side effect for patientsundergoing high dose RT. An awareness of when and to what extentthese skin reactions occur can assist nurses to plan appropriateinterventions.The results also indicate that MVPD has a role as a standardtreatment for the management of skin lesions secondary to RT, involvingthe epidermis and the dermis and suggest that the use of GV as a skincare treatment for these same lesions should be questioned. The resultscan be used by nurses in the development of a standardized approach to69skin care management for oncology patients undergoing RT. The currenttreatments for all types of radiation induced skin reactions, in theprovince of B.C, are based on the belief that dry healing methods willpromote faster healing rates. The results of this study indicate there ismaybe a lack of understanding in those individuals currently treatinglesions secondary to RT of the beneficial effects of moist healingmethods in the care of these lesions. An awareness of the principles ofmoist healing can assist the nurse in directing care strategies with thegoals of decreasing the healing time and reducing patient discomfort.Open lesions secondary to RT in this study occurred during thelast week of treatment or within the first two weeks following. Thismeans that the majority of the lesions occurred before the next follow-upappointment leaving the patient to cope with this side effect on theirown. Patients need to be aware of the early signs of skin breakdownand how to seek assistance. Nursing has a major role in providing thiseducation to patients. The provision of this information may helppatients to identify problems early thereby, facilitating the use of timelyinterventions. The establishment of a symptom management follow-upappointment system for patients to see nurses would increase earlyidentification and treatment of problems and help minimize the need forhospitalization for more severe symptoms.Itchiness of the skin is a common side effect experienced by70patients throughout their RT. The results indicate that patients in bothstudy groups at the time of lesion onset, experienced moderate levels ofitchiness. Following treatment with MVPD patients experienceddramatic relief. This observation suggests that MVPD may have someeffect on reducing itchiness prior to the occurrence of a lesion.The results also provide valuable information for nursing regardingthe importance of evaluating not only the rate of healing betweendifferent skin care products but also the need to consider the patient’scomfort and acceptability of the treatment. The withdrawal of patientsfrom the GV group was due to the negative properties associated withthe product. Even if GV had promoted a faster healing rate, which it didnot, the discomfort associated with the treatment limits its acceptability.Caregivers in general when evaluating the effectiveness of differenttreatments, must consider the impact on quality of life. This isextremely important for cancer patients undergoing multiple and/orlengthy treatment programs with numerous associated side effects.The findings also have implications for nursing education. In orderfor nurses to assess the effect RT has on the skin and determine themost appropriate treatment for these skin reactions she/he must possesadvanced knowledge in the areas of: (1) radiobiology; (2) the structures,functions and physiology of the skin; (3) the relationship between theeffects of RT on the cellular structure and tissues of the skin; (4) the71healing process; and (5) the principles underlying the various skin caremethods and products. Cancer treatment centres must take the lead inpreparing oncology nurses who can predict, minimize and identifystrategies to prevent and treat these skin reactions to achieve positivepatient outcomes. A grasp of all of these areas of knowledge and theirapplication should enhance the problem solving ability of nurses to dealwith simple and complex skin care situations.Finally, the theoretical framework used to guide this studyprovides direction for understanding the relationship between the effectsof RT on the skin, the principles of healing and the various factors thatinfluence the healing process. The theoretical framework enables nursesto understand the positive benefits of moist healing methods comparedto dry methods and provides guidance to develop a consistent approachto the care of radiation induced skin reactions. Use of this frameworkmay also guide further refinement of general skin care treatments.Recommendations for Further ResearchFindings of this study suggest ideas for further research in anumber of areas.1. The development of consistent evaluation tools are neededto systematically assess skin care treatments.(i). Further refinement of the method of assessing thephases of the healing process, in terms of grades of72healing, is required.(ii). Further testing and refinement of the method used toevaluate the characteristics of erythema and exudate isrequired.(iii). Further testing and refinement of the componentschosen to evaluated the level of discomfort are required.2. Given the small sample size and the convenience method ofsampling, this study should be replicated with a largersample to substantiate the findings related to rate ofhealing and discomfort levels.3. Furthermore additional control studies comparing MVPDwith other skin care methods, besides GV, are needed todetermine the best treatment for open skin lesionssecondary to RT.4. Exploratory studies evaluating the role of MVPD in earlyRISR are required to investigate more specifically its role inpreventing open skin lesions and reducing discomfort levels.In conclusion, it is hoped that further research will be conductedto increase the body of knowledge concerning skin care strategies forRISR. The aim of this research should be directed towards limiting theextent of the tissue damage, promoting faster healing rates, minimizingdiscomfort and promoting self maintenance by the patient.73ReferencesBarnett, A., Berkowitz, R.L., Mills, R., & Vistness, L.M. (1983).Comparison of synthetic adhesive moisture vapour permeable andfine mesh gauze dressings for split-thickness skin graft donorsites. The American Journal of Surgery, 145, 379-381.Berner, M., & Rotenberg, G. (1990). 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Care of the patient receiving radiation therapy.Nursing Clinics of North America, 17, 631-648.LiI4i::::::::::::1::::zzz::; * I—--— EE*EEEHEEEEEEEEEEECl) 3 CD 0 z CD CD -I, CD x ) 1 0. 0 Cl) CD -o -‘ 0 a C)V V CD D 0 xCD101Appendix BAssessment Flow Sheet80— Appendix BASSESSMENT FLOW SHEET ID #:DATE (IDmDATE ON STUDYA) ERYTHEMA•severity0 = none, 1 = Ihint2 =_bright, 3 = deep purple• area (cm x cm)B) EXUDATE•type’0 npne, 1 = serous2 = sero-sang, 3 = sang4 = 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 RELATEDTO TREATMENTG) OTHER (0-10)H) DAILY SKIN CAREData Collector’s Initials:81Appendix CSkin Care Protocol for the Aprlication of Gentian VioletProcedure 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 openlesion and the immediate surrounding tissue, working from the innerlesion area in a circular motion to the surrounding area. If a secondswab is required a new sterile swab is to be used.3. The open lesion after the application of Gentian Violet is left open tothe air.4. Record the lesion size by carefully tracing around the lesion edgesusing an Op-Site, Flexigrid sheet.82Appendix DSkin Care Protocol for the Application and Careof Open Lesions Using Moisture Vapour Permeable DressingsProcedure for the Application of Op-Site, Flexigrid:1. The open lesion and surrounding skin area should bethoroughly cleansed with sterile saline and dried.2. A border of at least 2 cm must be maintained around theopen lesion. Larger lesions may be covered using 2 sheetsof Op-Site, Flexigrid overlapping by at least 1 cm.3. Remove the backing from the dressing, hold the dressing byits carrier and remove the paper handle.4. Position the transparent dressing over the centre of thelesion and adhere it to the skin surrounding the lesionmaking sure all four corners of the dressing are secured.5. Record the lesion size by carefully tracing around thewound edges. Remove the grid. This procedure can berepeated 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-SiteFlexigrid film parallel with the skin. Repeat until the wholedressing is removed.2. For particularly fragile skin, the dressing may also be easedoff gently with warm soapy water.Procedure for the removal of excessive exudate that is threatening to liftthe dressing:1. Remove excess exudate with a syringe using an aseptictechnique.2. Patch the puncture site with another small piece of Op-Site,Flexigrid.83Appendix EPersonal and Medical History Form— PERSONAL AND MEDICAL HISTORY FORMI Personal HistoryID Code #:_________Sex: — DOB:_________Language:_________Residence:____________II Medical History and Radiation Therapy Treatment InformationTumour Site:_ _______Date Diagnosed:Previous Radiation Therapy: D Yes No Date:________Site:__________Total Dose:___ ____Previous Head & Neck Surgery: a Yes a No Date:_________Type:Radiation Treatment Plan, Site:_________ ______Field Area:_____Total Dose:_ ____Number of Fractions:_ _Start Date: Completed:_Breaks: a Yes a NoStopped:Started:Why:Medications:___ __Diabetic: Yes a NoDiagram of Radiation Treatment Field 4and Site of Open Lesion(s) Hx P.V.D.: a Yes a NoIII Skin AssessmentHistory of Skin Problems: Allergies____Cancer AcneOtherSkin Care Routine: Soap___Lotion____Cologne ShavingOther______ __ __ ___ __ _ _ _ __ _IV Study DataStart Date:_Randomization Date: MVPD a GV aStop Date:_Completed Treatment: a Yes a No Why?: —Comments:__84Appendix FGrade of Healing GrouDingsGrade 1 No reepithelialization present.Grade 2 Small sparse or spotty areas of reepithelialization present.Grade 3 Larger areas of reepithelialization. The smaller previousareas are now joining together to form larger areas.Grade 4 Complete reepithelialization or complete healing of thelesion.85Appendix GColour Groupings Measuring Erythema0= None. No change to skin colour.1 = Faint. A transparent slight reddening of the skin colour that doesnot fade with time,2 = Bright. A definite opaque reddening of the skin. The colour is brightand usually shiny in nature with edema noted,3 = Deep Purple/Red. A dull deep redc.ish/purple colour. i r. brightnessof the previous level is gone and replaced by a overall dull red.86Appendix HExudate GrouiingNone No exudate ispresent from thelesionSerous A clear transparentfluid present in andaround the lesion.Serous-sanguineous A faint reddishtransparent fluid inand around thelesion.Sanguineous A bloody opaquefluid in and aroundthe lesion.Prurient A greenish fluid inand around thelesion may alsohave an odour.87Appendix IPage 1 of 3Patient Information and Consent Form Comparison of Moisture VapourPermeable Dressings and Gentian Violet Application for the Managementof Open Skin Lesions Secondary to Radiation Therapy in Head and NeckCancer PatientsMy name is Barbara Korabek, I am a Registered Nurse currently inthe Masters of Nursing program at the University of British Columbia.I have worked in a cancer treatment centre for the last eight years. I amcurrently conducting a study evaluating different types of treatment forskin reactions that have resulted during the course of radiation therapy.The purpose of this study is to compare two types of treatmentused in the care of open skin areas that might occur as a result ofradiation therapy. One of the two types of treatments used in this studyis the application of Gentian Violet to the open skin area two to threetimes a day. Gentian Violet is a purple liquid that is applied directly toskin using sterile swabs. The second treatment is the use of a thin cleardressing that is applied directly to the open skin area and remains inplace for several days. Both types of treatment have been previouslyused in the care of skin reactions and to date, there has been noevidence of side effects from either type of skin care.It is unknown what percentage of patients receiving radiationtherapy will develop a small open area but it is important to note that notall patients do and if you do develop a small open area your radiationtherapy will not be compromised in any way. If you do develop a smallopen area you will be randomly assigned to use one of the two skin caretreatments. This means you will have an equal chance of being assignedto use either the Gentian Violet or the clear dressing treatments.If you consent to participate I will see you either before or afteryour next radiation therapy treatment at the British Columbia CancerAgency. At that time I will review this document with you and ask youto sign the document. After that I will ask you questions about yourgeneral health and skin care practices. I will see you again on your nexttreatment either before or directly after and then every day until youcomplete your course of radiation therapy. During these visits I willcheck your skin area where you are receiving treatment and ask you afew questions regarding your comfort level.If you have an open skin area at the end of your radiation therapytreatment you will be asked to come to the clinic twice a week until88Page 2 of 3your skin heals or for one month. If you do develop an open area onceyour radiation has completed you are asked to call your attendingphysician at the Cancer Clinic for instructions on your skin care. Thestudy concludes after skin has completely healed, and! or one monthafter you began the skin care treatment.I will instruct you or any members of your family you wish abouthow to use and apply the skin care treatments. While you are on thestudy 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 directlyfollowing your radiation therapy and then twice a week to assess yourskin, ask a few questions related to your comfort level and help you withyour skin care. If you agree, skin cultures and a photograph of your skinarea will be taken on the first day you start the skin care treatment andthen once a week until the study is completed.The study will require approximately 10 to 1 5 minutes of yourtime each treatment day for the skin assessment, performing thenecessary skin care and answering any questions you may have.Although there may be no direct benefit to you participating in thisstudy, the knowledge gained will be important to the future care of thistype of skin reaction.Your identity with the information obtained will be keptconfidential. To protect this confidentiality an identification number willbe used instead of your name on all forms related to the study. Theinformation obtained will only be used for scientific publications, reports,or presentations.Your participation in this study is entirely voluntary. If you decidenot to participate or at any time in the future you decide to withdrawfrom the study, your present and future care at the British ColumbiaCancer Agency will not be affected.89Page 3 of 3Evaluation of Gentian Violet and Moisture Vapour Permeable Dressing inthe Care of Open Skin Lesions Secondary to Radiation Therapy, PatientInformation and Consent Form.By signing this consent form, I indicate that I fully understand thepurpose of the study and my participation in it. I acknowledge that Ihave received a copy of the information and consent form. I have hadquestions answered to my satisfaction and I agree to participate in thestudy.I may contact Barbara Korabek at 877-6000 local 2503 or 937-0802 if I have further questions or require additional information. I mayalso contact her research supervisor who is, Dr. A. Hilton at Universityof British Columbia School of Nursing, 822-7498 if I have any questionsor concerns.(Witness) (Signature)(Date) (Date)90Appendix JSkin Culture ProceduresProcedure 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 thewound.Appendix KProcedure for Photoqrarhs1. Use camera on manual settings, turn camera on.2. Turn flash to TTL.3. Line up the white markings on the camera lens andpolarizer.4. Take a regional photo (1:7 magnification, F-stop 5.6).5. Take a close-up photo (1:4, 8).6. Use same magnifications and orientation during each visitfor consistency.7. Take two photos at each orientation.91


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