Nitropaste in Breast Reduction

Gynecomastia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04321967
• Other study ID #: GCO 19-0387
• Status: Withdrawn
• Phase: Phase 3
• Start date: August 20, 2019
• Est. completion date: November 1, 2022

Study information

• Verified date: January 2021
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Delayed Wound Healing
• Gynecomastia

Intervention

Drug:
• Nitroglycerin Paste
1g of 2% Nitroglycerin paste topical application
• Dermabond
Topical skin adhesive

Locations

Country	Name	City	State
United States	Mount Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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