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Nitropaste in Breast Reduction

Primary Purpose

Gynecomastia, Delayed Wound Healing

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nitroglycerin Paste
Dermabond
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gynecomastia focused on measuring Nitroglycerin paste, Scarring, Necrosis, Wound healing, Breast, Breast reduction

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nitroglycerine paste

Dermabond

Arm Description

The randomized breast will receive Nitroglycerine paste and Dermabond.

The control breast will receive Dermabond only

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
March 24, 2020
Last Updated
November 3, 2022
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT04321967
Brief Title
Nitropaste in Breast Reduction
Official Title
Topical Nitroglycerin as a Mechanism for Cutaneous Vaso-modulation and Improved Wound Healing After Breast Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit patients
Study Start Date
August 20, 2019 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecomastia, Delayed Wound Healing
Keywords
Nitroglycerin paste, Scarring, Necrosis, Wound healing, Breast, Breast reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare Provider
Masking Description
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.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nitroglycerine paste
Arm Type
Experimental
Arm Description
The randomized breast will receive Nitroglycerine paste and Dermabond.
Arm Title
Dermabond
Arm Type
Placebo Comparator
Arm Description
The control breast will receive Dermabond only
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin Paste
Intervention Description
1g of 2% Nitroglycerin paste topical application
Intervention Type
Drug
Intervention Name(s)
Dermabond
Intervention Description
Topical skin adhesive
Primary Outcome Measure Information:
Title
Change in Vancouver Scar Scoring (VSS)
Description
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.
Time Frame
First post-op visit (0 weeks post op) and last visit at 12 months
Secondary Outcome Measure Information:
Title
Number of occurrences of wound breakdown
Description
Change in number of occurrence of necrosis and/or wound breakdown at 12 months as compared to the first post-op visit
Time Frame
12 months
Title
Number of side-effects of Nitroglycerin use
Description
Side effects of nitroglycerine use measured as a composite of side effects which includes pre-syncope, syncope, chest pains and headache.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Taub, M.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD and related data dictionaries available. The PI does not plan to share data at the conclusion of the study beyond what is published

Learn more about this trial

Nitropaste in Breast Reduction

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