Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT04321967
Status:
WITHDRAWN
Last Update Posted:
2022-11-08
First Post:
2020-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nitropaste in Breast Reduction
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Study Overview
Official Title:
Topical Nitroglycerin as a Mechanism for Cutaneous Vaso-modulation and Improved Wound Healing After Breast Reduction
Status:
WITHDRAWN
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: