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Vasodilator

Nitropaste for Chest Masculinizing Surgery

Phase 4
Recruiting
Led By John T Stranix, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients (18 or older) of any gender identity undergoing chest masculinizing surgery with double incision and free nipple grafting.
Be older than 18 years old
Must not have
Patients not utilizing double incision pattern
Patients taking phosphodiesterase inhibitors (e.g. Sildenafil, tadalafil, vardenafil)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up will be tracked up until 3 months post-op
Awards & highlights

Summary

This trial investigates the potential use of Nitropaste, a topical agent containing 2% nitroglycerin, in reducing wound complications in patients undergoing chest masculinizing surgery. Nitropaste is

Who is the study for?
This trial is for individuals undergoing chest masculinizing surgery to treat gender dysphoria. There are no specific inclusion or exclusion criteria provided, so it's important to contact the study organizers for detailed eligibility requirements.
What is being tested?
The trial is testing Nitropaste, a topical ointment with nitroglycerin that dilates blood vessels. It aims to see if applying this ointment can reduce wound complications after chest masculinizing surgery.
What are the potential side effects?
Nitropaste generally has low rates of side effects and is well tolerated. Specific side effects aren't listed but may include headache, dizziness, or skin irritation at the application site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am an adult planning to undergo chest masculinizing surgery with nipple grafting.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My surgery does not involve a double incision technique.
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I am currently taking medication for ED, such as Viagra or Cialis.
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I am under 18 years old.
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I am not getting a free nipple graft.
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I am currently taking riociguat.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~will be tracked up until 3 months post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and will be tracked up until 3 months post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Free Nipple Graft Take
Wounds
Secondary outcome measures
Complications
Readmission
Revision
+1 more

Side effects data

From 2019 Phase 4 trial • 66 Patients • NCT02209636
38%
Non-serious adverse events
3%
Hospitalization
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lanthanum Carbonate
Placebo
Placebo- Phosphorus Balance Sub-study
Lanthanum Carbonate- Phosphorus Balance Sub-study

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Nitropaste groupExperimental Treatment1 Intervention
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.
Group II: No nitropaste groupActive Control1 Intervention
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.

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Who is running the clinical trial?

University of VirginiaLead Sponsor
771 Previous Clinical Trials
1,284,041 Total Patients Enrolled
John T Stranix, MDPrincipal InvestigatorUVA
~73 spots leftby Aug 2025
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