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 been shown to improve skin flap survival in an animal model. The objective of this study was to evaluate whether 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 with 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, British Columbia, Canada). Patients with a medical history that precluded the administration ofnitroglycerin were excluded from the study. The target sample size was 400 patients. Nitroglycerin ointment (45 mg) 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 to the treatment group and 80 to theplacebo group). Mastectomy flap necrosis developed in 27 patients (33.8 percent) receiving placebo and in 13 patients (15.3 percent) receiving nitroglycerin ointment; the between-group difference was 18.5 percent (p = 0.006; 95 percent CI, 5.3 to 31.0 percent). Postoperative complications were similar in both groups [nitroglycerin, 22.4 percent (19 of 85); placebo, 28.8 percent (23 of 80)]. CONCLUSIONS: 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. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.
RCT Entities:
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 been shown to improve skin flap survival in an animal model. The objective of this study was to evaluate whether 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 with 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, British Columbia, 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 (45 mg) 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 to the treatment group and 80 to the placebo group). Mastectomy flap necrosis developed in 27 patients (33.8 percent) receiving placebo and in 13 patients (15.3 percent) receiving nitroglycerin ointment; the between-group difference was 18.5 percent (p = 0.006; 95 percent CI, 5.3 to 31.0 percent). Postoperative complications were similar in both groups [nitroglycerin, 22.4 percent (19 of 85); placebo, 28.8 percent (23 of 80)]. CONCLUSIONS: 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. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.
Authors: Walter P Weber; Martin Haug; Christian Kurzeder; Vesna Bjelic-Radisic; Rupert Koller; Roland Reitsamer; Florian Fitzal; Jorge Biazus; Fabricio Brenelli; Cicero Urban; Régis Resende Paulinelli; Jens-Uwe Blohmer; Jörg Heil; Jürgen Hoffmann; Zoltan Matrai; Giuseppe Catanuto; Viviana Galimberti; Oreste Gentilini; Mitchel Barry; Tal Hadar; Tanir M Allweis; Oded Olsha; Maria João Cardoso; Pedro F Gouveia; Isabel T Rubio; Jana de Boniface; Tor Svensjö; Susanne Bucher; Peter Dubsky; Jian Farhadi; Mathias K Fehr; Ilario Fulco; Ursula Ganz-Blättler; Andreas Günthert; Yves Harder; Nik Hauser; Elisabeth A Kappos; Michael Knauer; Julia Landin; Robert Mechera; Francesco Meani; Giacomo Montagna; Mathilde Ritter; Ramon Saccilotto; Fabienne D Schwab; Daniel Steffens; Christoph Tausch; Jasmin Zeindler; Savas D Soysal; Visnu Lohsiriwat; Tibor Kovacs; Anne Tansley; Lynda Wyld; Laszlo Romics; Mahmoud El-Tamer; Andrea L Pusic; Virgilio Sacchini; Michael Gnant Journal: Breast Cancer Res Treat Date: 2018-09-04 Impact factor: 4.872