Nitropaste in Breast Reduction

Study Overview
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Brief Summary
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The purpose of this study is evaluate the effect of Nitroglycerin paste on wound healing and scarring. Previous research has shown that Nitroglycerin paste can improve the blood flow to a wound, which may be associated with better wound healing, and ultimately, better scarring.

Detailed Description
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This will be a single-center, patient-blinded, (breast) randomized trial utilizing nitroglycerin paste on their breast reduction scar. The study team aims to randomize 100 patients, or 200 breasts. Each patient will receive treatment, but the breast that received treatment will be random. This will allow for a control breast to compare to. Patients will be followed for 12 months postoperatively to observe wound healing.

Official Title
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Topical Nitroglycerin as a Mechanism for Cutaneous Vaso-modulation and Improved Wound Healing After Breast Reduction

Conditions
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Gynecomastia, Delayed Wound Healing

Intervention / Treatment
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* Drug: Nitroglycerin Paste
* Drug: Dermabond


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are female and transmen Undergoing bilateral breast reduction via Mount Sinai Plastic Surgery Clinic Reduction must be performed via Wise incisional pattern Exclusion Criteria: Patients who are male or transwomen Patients who are under 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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
Interventional Model Description: Patients who agree to participate will be randomized during their bilateral breast reduction procedure. Each patient will be randomized to LEFT BREAST or RIGHT BREAST. The randomization result will determine which breast receives the nitroglycerin paste. Their breast reduction will be done using the Wise pattern, and all incisions will be sealed with Dermabond. At the conclusion of the procedure, 1g of topical nitroglycerin (2%) will be placed on the breast which the randomizer indicated. Patients will be monitored for AEs during the remainder of their hospital stay.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitroglycerine paste<br>The randomized breast will receive Nitroglycerine paste and Dermabond. | Drug: Nitroglycerin Paste<br>* 1g of 2% Nitroglycerin paste topical application<br>Drug: Dermabond<br>* Topical skin adhesive<br>|
| Placebo Comparator: Dermabond<br>The control breast will receive Dermabond only | Drug: Dermabond<br>* Topical skin adhesive<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vancouver Scar Scoring (VSS) | Change in Vancouver Scar Scoring at 12 as compared to first post visit. VSS is a standardized scar appearance protocol - full score from 0-13, with higher score indicating poorer health outcomes. | First post-op visit (0 weeks post op) and last visit at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of occurrences of wound breakdown | Change in number of occurrence of necrosis and/or wound breakdown at 12 months as compared to the first post-op visit | 12 months | 
| Number of side-effects of Nitroglycerin use | Side effects of nitroglycerine use measured as a composite of side effects which includes pre-syncope, syncope, chest pains and headache. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nitroglycerin paste, Scarring, Necrosis, Wound healing, Breast, Breast reduction