Gynecomastia Clinical Trial
Official title:
Topical Nitroglycerin as a Mechanism for Cutaneous Vaso-modulation and Improved Wound Healing After Breast Reduction
Verified date | January 2021 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
United States,
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 |
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