Nitropaste in Breast Reduction

Phase 3

Withdrawn

• Conditions: Delayed Wound Healing; Gynecomastia
• Interventions: Drug: Nitroglycerin Paste; Drug: Dermabond

• Registration Number: NCT04321967
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-08-20
• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-26
• Status Verified: 2021-01
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nitroglycerine paste	Nitroglycerin Paste	The randomized breast will receive Nitroglycerine paste and Dermabond.
Nitroglycerine paste	Dermabond	The randomized breast will receive Nitroglycerine paste and Dermabond.
Dermabond	Dermabond	The control breast will receive Dermabond only

Primary Outcome Measures

Name	Time	Method
Change in Vancouver Scar Scoring (VSS)	First post-op visit (0 weeks post op) and last visit at 12 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇺🇸 New York, New York, United States