Nitropaste in Chest Masculinizing Surgery

This study is looking at whether a topical ointment called Nitro-Bid 2% (nitroglycerin) can help reduce wound complications for people having chest masculinizing surgery with free nipple grafting. Researchers want to see if applying Nitro-Bid to the chest during surgery helps the nipple grafts heal better and reduces other wound issues. You might be able to join if you are an adult (18 or older) having this specific type of chest masculinizing surgery. The study is currently unclear about its recruitment status, but plans to enroll 256 participants. The study is interested in how Nitro-Bid affects the RAF mechanism in the body, which is related to cell growth and survival.

Study design
This is a randomized, single-blinded study comparing Nitro-Bid to no Nitro-Bid, planning to enroll 256 participants.
What's involved
If you participate, Nitro-Bid will be applied during your surgery. You will have follow-up visits at 5 days, 2 weeks, and 6 weeks after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 weeks after surgery to assess nipple graft take and wound healing.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06428669

Effect of Nitropaste in Chest Masculinizing Surgery

UNKNOWN
PHASE4Ages 18+InterventionalTreatment
University of Virginia
~256 participants
Updated 2024-06-06 on ClinicalTrials.gov
What's tested:Nitro-Bid 2 % Topical Ointment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Free Nipple Graft Take
Measured over Will be assessed at 5 days, 2 weeks, 6 weeks post-op
+1 more outcome measured
Gender Dysphoria
1 sites across 1 states
Virginia1
  • John T Stranix, MD · PRINCIPAL_INVESTIGATOR · UVA

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Free Nipple Graft TakeWill be assessed at 5 days, 2 weeks, 6 weeks post-op

    Rate of partial nipple graft loss (0-50%, 50% or more) or Complete nipple graft loss

  • WoundsWill be assessed at 5 days, 2 weeks, 6 weeks post-op

    Rate of superficial wound, deep wound, delayed wound healing