title: Effects of nitroglycerin ointment on mastectomy flap necrosis in immediate breast reconstruction: a randomized controlled trial.
abstract: 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.
  
  
  METHODS
  Therapeutic, I.
authors.affiliation: Vancouver, British Columbia, Canada From the Division of Plastic and Reconstructive Surgery, University of British Columbia.
authors.forename: Perry
authors.initials: P
authors.lastname: Gdalevitch
authors.forename: Nancy
authors.initials: N
authors.lastname: Van Laeken
authors.forename: Seokjae
authors.initials: S
authors.lastname: Bahng
authors.forename: Adelyn
authors.initials: A
authors.lastname: Ho
authors.forename: Esta
authors.initials: E
authors.lastname: Bovill
authors.forename: Peter
authors.initials: P
authors.lastname: Lennox
authors.forename: Penelope
authors.initials: P
authors.lastname: Brasher
authors.forename: Sheina
authors.initials: S
authors.lastname: Macadam
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000473:pathology / Q000601:surgery*; D001955:British Columbia; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection; D006085:Graft Survival; D006801:Humans; D016462:Mammaplasty / Q000009:adverse effects / Q000379:methods*; D008408:Mastectomy / Q000379:methods*; D008875:Middle Aged; D009336:Necrosis / Q000188:drug therapy / Q000473:pathology; D005996:Nitroglycerin / Q000627:therapeutic use*; D009824:Ointments / Q000627:therapeutic use; D011183:Postoperative Complications / Q000188:drug therapy / Q000473:pathology; D012016:Reference Values; D018570:Risk Assessment; D013524:Surgical Flaps / Q000009:adverse effects / Q000473:pathology*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D009824:Ointments; D005996:Nitroglycerin