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

Trial Summary

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.

Is Nitropaste generally safe for use in humans?

Nitropaste (nitroglycerin paste) is generally considered safe, but some people may experience skin reactions like redness or irritation at the application site. These reactions are believed to be caused by the delivery system rather than the nitroglycerin itself. ^{1 2 3 4 5}

How is the drug Nitropaste unique for chest masculinizing surgery?

Nitropaste is unique because it is a topical vasodilator (a substance that widens blood vessels) which may improve blood flow and skin flap survival, potentially reducing complications like tissue necrosis (tissue death) after surgery. This approach is different from other treatments that might not focus on enhancing blood flow to surgical areas. ^{1 3 5 6 7}

What is the purpose of this trial?

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.

Research Team

John T Stranix, MD

Principal Investigator

UVA

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Topical nitroglycerin: a potential treatment for impotence. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Adverse dermatologic reaction to transdermal nitroglycerin. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of nitroglycerin ointment on mastectomy flap necrosis in immediate breast reconstruction: a randomized controlled trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Successful treatment of cerebral vasospasm by use of transdermal nitroglycerin ointment (Nitropaste). [2021]

5. England pubmed.ncbi.nlm.nih.gov

Intravenous nitroglycerin does not preserve gastric microcirculation during gastric tube reconstruction: a randomized controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Nitroglycerin-controlled circulation in orthognathic surgery. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

A single postoperative application of nitroglycerin ointment does not increase survival of cutaneous flaps and grafts. [2019]