Mastectomy Flap Necrosis Clinical Trial
Official title:
Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis
Background:
Mastectomy flap necrosis (MFN) is a common complication that affects recovery,
reconstructive success and aesthetic outcome. Nitroglycerin (NTG) ointment is a potent
topical vasodilator that increases local blood flow by dilating arteries and veins without
altering the ratio of pre- to post-capillary resistance. There are no studies that evaluate
whether the application of NTG ointment in patients undergoing Skin-sparing mastectomy (SSM)
or nipple-sparing mastectomy (NSM) and immediate reconstruction decreases the rate of
mastectomy flap necrosis.
Objective:
To evaluate if the post-operative application of NTG ointment improve rates of MFN in
patients undergoing SSM or NSM with immediate breast reconstruction compared to patients
receiving placebo.
Hypothesis:
In patients undergoing SSM and immediate breast reconstruction there will be a decrease in
the rate of MFN in those who receive NTG ointment compared to those who receive placebo.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment