Nitropaste for Chest Masculinizing Surgery

Overseen By Rachel H Park, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Virginia

Must not be taking: Phosphodiesterase inhibitors, Guanylate cyclase stimulators

Disqualifiers: Minors, Prisoners, Nitropaste allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

256 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies a treatment called nitropaste, a cream that improves blood flow, to determine if it can reduce wound problems after chest masculinizing surgery. The researchers aim to discover whether applying nitropaste around surgical sites results in fewer complications compared to standard care alone. Participants will receive either nitropaste or the regular post-surgery dressing. This trial targets adults undergoing chest masculinizing surgery with specific techniques, such as double incision and nipple grafting. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved nitropaste can benefit more patients.

Will I have to stop taking my current medications?

If you are taking medications like Sildenafil, Tadalafil, Vardenafil, or Riociguat, you will need to stop taking them to participate in this trial.

What is the safety track record for Nitropaste?

Research has shown that nitropaste, a type of nitroglycerin paste, is generally safe and easy to use. Studies have found that it usually causes only minor skin reactions, such as redness or irritation at the application site. In other uses, like aiding wound healing, it improves blood flow, which supports recovery. Importantly, no reports of serious side effects exist, and complications are rare. This makes nitropaste a promising option for reducing wound problems in surgeries. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for chest masculinizing surgery focus on surgical techniques and post-operative care. However, researchers are exploring nitropaste as a novel addition to the standard procedure. Nitropaste is unique because it could enhance healing and improve blood flow to the surgical area by releasing nitric oxide, a compound known for its role in blood vessel dilation. This could potentially reduce complications and improve outcomes for patients undergoing this surgery, making it an exciting area of research.

What evidence suggests that nitropaste might be an effective treatment for reducing wound complications in chest masculinizing surgery?

In this trial, participants in the Nitropaste group will undergo standard chest masculinizing surgery followed by the application of nitropaste, a cream containing 2% nitroglycerin, to improve blood flow to wounds and potentially enhance healing. Research has shown that nitropaste significantly lowers the risk of partial nipple graft loss, with no complete graft loss observed. In past studies, 83.3% of patients using nitropaste experienced smooth wound healing, highlighting its promise for reducing wound problems. Nitropaste is known for having few side effects and is generally well tolerated. While primarily used for chest pain (angina), its ability to widen blood vessels suggests it could help in surgeries like chest masculinizing surgery by possibly reducing wound issues. Participants in the No Nitropaste group will receive the same surgery without the application of nitropaste. ^{2 3 4 5 6}

Who Is on the Research Team?

John T Stranix, MD

Principal Investigator

UVA

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am an adult planning to undergo chest masculinizing surgery with nipple grafting.

Exclusion Criteria

Prisoners

Patients allergic to nitropaste

My surgery does not involve a double incision technique.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Treatment

Participants undergo chest masculinizing surgery with or without nitropaste application

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for wound complications and graft condition at 5 days, 2 weeks, and 6 weeks post-op

6 weeks

3 visits (in-person)

Extended Follow-up

Participants are monitored for any complications, need for revision, or readmission up to 3 months post-op

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Nitropaste

Trial Overview

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.

How Is the Trial Designed?

Group I: Nitropaste group Experimental Treatment 1 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 group Active Control 1 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.

Nitropaste is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Nitropaste for:

• Angina pectoris

Approved in European Union as Nitropaste for:

• Angina pectoris

Approved in Canada as Nitropaste for:

• Angina pectoris

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

In a study involving five patients with intracranial vasospasm due to subarachnoid hemorrhage, the application of transdermal nitroglycerin ointment (Nitropaste) resulted in mild to moderate improvement in vasospasm as observed through angiographic evaluations.

Nitropaste offers a simple and noninvasive method for potentially reducing intracranial vasospasm, suggesting it could be a useful treatment option in this clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful treatment of cerebral vasospasm by use of transdermal nitroglycerin ointment (Nitropaste). Lesley, WS., Lazo, A., Chaloupka, JC., et al.[2021]

In a study involving 173 surgical repairs, a single postoperative application of nitroglycerin ointment did not significantly improve the survival rates of flaps and grafts compared to a control ointment (polysporin).

The complication rates for flaps and grafts treated with nitroglycerin (12.5%) were similar to those treated with the control (8.4%), indicating that nitroglycerin does not enhance flap and graft survival in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single postoperative application of nitroglycerin ointment does not increase survival of cutaneous flaps and grafts. Dunn, CL., Brodland, DG., Griego, RD., et al.[2019]

Transdermal nitroglycerin systems, like the Transderm-Nitro patch, have a very low incidence of adverse effects, making them generally safe for use.

In a case study of a 63-year-old male patient, localized skin reactions were observed at the patch sites, suggesting that the reaction may be due to the transdermal delivery system rather than the nitroglycerin itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse dermatologic reaction to transdermal nitroglycerin. Letendre, PW., Barr, C., Wilkens, K.[2019]

In a randomized controlled trial involving 165 patients undergoing mastectomy and immediate breast reconstruction, the use of nitroglycerin ointment significantly reduced the rate of mastectomy flap necrosis from 33.8% in the placebo group to 15.3% in the treatment group (p = 0.006).

The application of nitroglycerin ointment was found to be safe, with similar rates of postoperative complications between the nitroglycerin group (22.4%) and the placebo group (28.8%), indicating its efficacy without increasing risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of nitroglycerin ointment on mastectomy flap necrosis in immediate breast reconstruction: a randomized controlled trial. Gdalevitch, P., Van Laeken, N., Bahng, S., et al.[2021]

Nitroglycerin was found to be a safe and effective agent for controlling blood circulation during maxillary and mandibular osteotomies, helping to reduce blood loss during surgery.

In a study of nine patients, the use of nitroglycerin resulted in an estimated blood loss of 439 ml, with only slight decreases in hemoglobin and hematocrit levels, indicating its efficacy in managing blood pressure without significant adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nitroglycerin-controlled circulation in orthognathic surgery. Golia, JK., Woo, R., Farole, A., et al.[2019]

In a study of 32 patients undergoing oesophagectomy, intravenous nitroglycerin did not improve microvascular blood flow or oxygenation in the gastric fundus during gastric tube reconstruction, as both the nitroglycerin and control groups experienced similar decreases in these measures.

Postoperative leakage occurred in 13% of patients receiving nitroglycerin compared to 31% in the control group, but this difference was not statistically significant, suggesting that nitroglycerin may not effectively reduce leakage rates in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous nitroglycerin does not preserve gastric microcirculation during gastric tube reconstruction: a randomized controlled trial. Buise, M., van Bommel, J., Jahn, A., et al.[2022]

In a double-blind study with 26 impotent subjects, 2% nitroglycerin paste significantly increased penile circumference compared to a placebo, with 18 out of 26 subjects showing improvement (p < 0.05).

Ultrasonography confirmed that nitroglycerin paste enhanced blood flow and diameter in the cavernous arteries, suggesting it could be a promising new treatment for erectile dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical nitroglycerin: a potential treatment for impotence. Owen, JA., Saunders, F., Harris, C., et al.[2022]

Citations

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withpower.com

withpower.com/trial/nitropaste-for-chest-masculinizing-surgery-bee2e

Nitropaste for Chest Masculinizing Surgery

In a double-blind study with 26 impotent subjects, 2% nitroglycerin paste significantly increased penile circumference compared to a placebo, with 18 out of 26 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11149752/

Topical Nitropaste Reduces Partial Free Nipple Graft Loss ...

Overall, partial nipple graft loss rate was 36.6%, with no total graft loss observed. Controlling for smoking status, incidence of partial graft loss was ...

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journals.lww.com

journals.lww.com/prsgo/fulltext/2024/06006/topical_nitropaste_reduces_partial_free_nipple.15.aspx

Topical Nitropaste Reduces Partial Free Nipple Graft Loss...

Overall, partial nipple graft loss rate was 36.6%, with no total graft loss observed. Controlling for smoking status, incidence of partial graft loss was ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04321967

NCT04321967 | Nitropaste in Breast Reduction

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, ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40548981/

Topical nitroglycerin for high-risk orthopaedic trauma wounds

No systemic adverse effects were reported. Wound healing was uneventful in 15 patients (83.3%), while 3 (16.7%) developed wound dehiscence and ...

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trialx.com

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Effect of Nitropaste in Chest Masculinizing Surgery

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 ...