Gynecomastia, Delayed Wound Healing
Conditions
Keywords
Nitroglycerin paste, Scarring, Necrosis, Wound healing, Breast, Breast reduction
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.
Interventions
DRUGNitroglycerin Paste
1g of 2% Nitroglycerin paste topical application
DRUGDermabond
Topical skin adhesive
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
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.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vancouver Scar Scoring (VSS) | First post-op visit (0 weeks post op) and last visit at 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of occurrences of wound breakdown | 12 months | 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 | 12 months | Side effects of nitroglycerine use measured as a composite of side effects which includes pre-syncope, syncope, chest pains and headache. |
Countries
United States
Outcome results
None listed