Nitropaste in Breast Reduction

Mount Sinai Health System

Status and phase: Withdrawn; Phase 3

Conditions: Gynecomastia; Delayed Wound Healing

Treatments: Drug: Dermabond; Drug: Nitroglycerin Paste

Study type: Interventional

Funder types: Other

Identifiers

NCT04321967

GCO 19-0387

Details and patient eligibility

About

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.

Full description

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.

Sex: Female

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Nitroglycerine paste

Experimental group

Description:

The randomized breast will receive Nitroglycerine paste and Dermabond.

Treatment:

Drug: Dermabond

Drug: Nitroglycerin Paste

Dermabond

Placebo Comparator group

Description:

The control breast will receive Dermabond only

Treatment:

Drug: Dermabond