Effect of Nitropaste in Chest Masculinizing Surgery

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT06428669
Phase
PHASE4
Status
Recruiting
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Conditions

  • Gender Dysphoria

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nitro-Bid 2 % Topical Ointment — DRUG
    Intervention group will get 30mg of Nitro-Bid topical ointment applied over the chest (15mg/ 1 packet on each side) one time intra-operatively

Study Details

Nitropaste is a topical agent that contains 2% nitroglycerin. It is an effective vascular smooth dilator, with more powerful effect on venous vasculature than arterial vasculature. While its main indication is for angina pectoris, there have been many studies showing improved survival of axial and random pattern flaps. Furthermore, recent clinical studies highlight significantly decreased mastectomy flap wound complication and need for sharp debridement. Nitropaste has low rates of side effects and is very well tolerated in general. To this date, there's no study that investigates its utility on patients who are undergoing chest masculinizing surgery. The purpose of this study is to investigate the potential utility of nitropaste in reducing rates of wound complications in patients undergoing chest masculinizing surgery.

Key Dates

Start date
Aug 15, 2022
Status verified
Jun 2024
Primary completion
Aug 31, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
256 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: No nitropaste group
    Participants get standard of care chest masculinizing surgery utilizing double incision and free nipple grafting surgery. They will get standard dressing applied, which includes Xeroform bolster over the nipple grafts + Tegederm over the bolster and surgical site and instructed not to remove the dressing until they come to clinic on POD5 for bolster take down.
  • Experimental: Nitropaste group
    Participants get standard of care chest masculinizing surgery utilizing double incision and free nipple grafting surgery. They will then get 2 packets of nitropaste applied (1 on each chest) around the free nipple graft and surgical sites. They will then get standard dressing applied, which includes Xeroform bolster over the nipple grafts + Tegederm over the bolster and surgical site and instructed not to remove the dressing until they come to clinic on POD5 for bolster take down.

Primary Outcome Measure

Free Nipple Graft Take [ Time Frame: Will be assessed at 5 days, 2 weeks, 6 weeks post-op ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia Medical CenterCharlottesvilleVirginia22902
Rachel H Park, MD
[email protected]
571-428-7278

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By research site
University of Virginia Medical Center· Charlottesville, VA

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