Recruiting

Nitropaste

Sponsor:

University of Virginia

Code:

NCT06428669

Conditions

Gender Dysphoria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nitro-Bid 2 % Topical Ointment

Study Details

Brief summary:

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.

Conditions

Gender Dysphoria

Study ID

NCT06428669

Start date

Aug 15, 2022

Status verified date

Jun, 2024

Completion date

Nov, 2025

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Any adult (18 or older) patients of any gender identity who are undergoing chest masculinizing surgery with double incision and free nipple grafting.

Exclusion Criteria:

  • Minor patients (younger than 18)
  • Anyone who's not getting free nipple grafting
  • Anyone who's not utilizing double incision pattern
  • Prisoners, anyone who is allergic to nitropaste
  • Anyone who is taking phosphodiesterase inhibitor (ex)Sildenafil, tadalafil, vardenafil)
  • Anyone who's taking soluble guanylate cyclase stimulator riociguatdz

Study Design

Enrollment

256 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Nitro-Bid 2 % Topical Ointment

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Rachel H Park, MD

434-327-2140rhp7gu@hscmail.mcc.virginia.edu

Locations

University of Virginia Medical Center

Recruiting

Charlottesville, Virginia, United States, 22902

Contacts

Rachel H Park, MD

571-428-7278rhp7gu@hscmail.mcc.virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Jun 6, 2024

Last verified

Jun, 2024

Keywords

  • Gender affirming surgery
  • Chest masculinizing Surgery
  • Nitropaste
  • Wound healing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2024-06-06.