Nitropaste in Breast Reduction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-20

Study Completion Date

2022-11-01

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.

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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.

Conditions

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Gynecomastia Delayed Wound Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

The patient will be masked and will not know which breast received the nitropaste. The investigator who applied nitropaste will know which breast was treated, but the investigator who conducts the follow-up visits will not.

Study Groups

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Nitroglycerine paste

The randomized breast will receive Nitroglycerine paste and Dermabond.

Group Type EXPERIMENTAL

Nitroglycerin Paste

Intervention Type DRUG

1g of 2% Nitroglycerin paste topical application

Dermabond

Intervention Type DRUG

Topical skin adhesive

Dermabond

The control breast will receive Dermabond only

Group Type PLACEBO_COMPARATOR

Dermabond

Intervention Type DRUG

Topical skin adhesive

Interventions

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Nitroglycerin Paste

1g of 2% Nitroglycerin paste topical application

Intervention Type DRUG

Dermabond

Topical skin adhesive

Intervention Type DRUG

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