Nitropaste in Breast Reduction

NCT04321967 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: GCO 19-0387
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecomastia; Delayed Wound Healing

Keywords

Nitroglycerin paste; Scarring; Necrosis; Wound healing; Breast; Breast reduction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of occurrences of wound breakdown

  12 months

• Number of side-effects of Nitroglycerin use

  12 months

Study Arms (2)

Nitroglycerine paste

EXPERIMENTAL

The randomized breast will receive Nitroglycerine paste and Dermabond.

Drug: Nitroglycerin Paste; Drug: Dermabond

Dermabond

PLACEBO COMPARATOR

The control breast will receive Dermabond only

Drug: Dermabond

Interventions

Nitroglycerin Paste DRUG

1g of 2% Nitroglycerin paste topical application

Nitroglycerine paste

Dermabond DRUG

Topical skin adhesive

Dermabond; Nitroglycerine paste

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who are female and transmen
• Undergoing bilateral breast reduction via Mount Sinai Plastic Surgery Clinic
• Reduction must be performed via Wise incisional pattern

You may not qualify if:

• Patients who are male or transwomen
• Patients who are under 18 years of age

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Gynecomastia; Cicatrix; Necrosis

Interventions

octyl 2-cyanoacrylate

Condition Hierarchy (Ancestors)

Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Taub, M.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 26, 2020
• Study Start: August 20, 2019
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 8, 2022

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)