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Effects of nitroglycerin ointment on mastectomy flap necrosis in immediate breast reconstruction : a randomized controlled trial

University of British Columbia

Background : Mastectomy flap necrosis is a common complication of immediate breast reconstruction that impacts recovery time and reconstructive success. Nitroglycerin ointment is a topical vasodilator that has shown to improve skin flap survival in animal models. The objective of this study was to evaluate if the application of nitroglycerin ointment to the breast skin after mastectomy and immediate reconstruction causes a decrease in the rate of mastectomy flap necrosis compared to placebo. Methods : This study was conducted as a randomized controlled trial and included patients aged 21 to 69 years undergoing mastectomy and immediate breast reconstruction at the University of British Columbia affiliated hospitals (Vancouver, Canada). Patients with a medical history that precluded the administration of nitroglycerin were excluded from the study. The target sample size was 400 patients. Nitroglycerin ointment (45mg) or a placebo was applied to the mastectomy skin at the time of surgical dressing. Results : The trial was stopped at the first interim analysis after 165 patients had been randomized (85 treatment vs. 80 placebo). Mastectomy flap necrosis developed in 27 patients (33.8%) receiving placebo and in 13 patients (15.3%) receiving nitroglycerin ointment; between-group difference = 18.5% (p=0.006, 95% CI : 5.3% to 31.0%). Post-operative complications were similar in both groups (nitroglycerin : 22.4% (19/85) vs. placebo : 28.8%, (23/80)). Conclusion : In patients undergoing mastectomy and immediate reconstruction, there was a marked reduction in mastectomy flap necrosis in patients who received nitroglycerin ointment. Nitroglycerin ointment application is a simple, safe and effective way to help prevent mastectomy flap necrosis.

Text

2015-01-20

Attribution-NonCommercial-NoDerivs 2.5 Canada

http://hdl.handle.net/2429/51934

Surgery

University of British Columbia

UBCV

http://creativecommons.org/licenses/by-nc-nd/2.5/ca/