Mastectomy Flap Necrosis
Conditions
Brief summary
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.
Interventions
Nitroglycerin ointment will be applied to mastectomy skin flaps at the end of surgery. A maximum of 7.5cm strip of 2% Nitroglycerin ointment will be applied (equivalent to a maximal dose of 45mg)
Polysporin ointment will be applied as the control ointment on the mastectomy flap skin at the end of surgery. A maximum of 7.5cm strip of ointment will be applied to the skin.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients who undergo SSM or NSM with immediate alloplastic or autologous breast reconstruction * Unilateral and bilateral cases (in bilateral cases only the mastectomy performed by the general surgeon will be included. This will avoid the potential effect of absorption of nitroglycerin from one breast to the other) * Patients older than 21 and less than 65
Exclusion criteria
* Patient declining inclusion in the study * Patient with medical history that precludes the administration of nitroglycerin, i.e. a medical history significant for * Acute circulatory failure accompanied by clear hypotension * Myocardial insufficiency related to obstruction * Use of sildenafil, vardenafil & tadalafil * Use of beta-blockers, calcium channel blockers, diuretics or phenothiazides * Salicylates (ASA) * Alteplase * Recent history of MI or cardiac insufficiency * Anemia, severe * Cerebral hemorrhage or recent head trauma * Glaucoma * Hepatic function impairment, severe * Hyperthyroidism * Hypertrophic cardiomyopathy * Hypotension * Sensitivity to nitrites * Patient with a history of mantle radiation * Patient with an allergy to polysporin or any of its ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mastectomy Flap Necrosis | 1 month post operative |
Countries
Canada
Outcome results
None listed