Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis

Conditions
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Mastectomy Flap Necrosis

Intervention / Treatment
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* Drug: nitroglycerin ointment
* Drug: Polysporin ointment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Polysporin Control<br>Patients in control group will receive polysporin ointment application. Polysporin ointment will be made to look like Nitroglycerin ointment. | Drug: Polysporin ointment<br>* 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.<br>|
| Active Comparator: Nitroglycerin<br>Patients in treatment group will receive nitroglycerin ointment application | Drug: nitroglycerin ointment<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mastectomy Flap Necrosis |  | 1 month post operative |