Effect of Nitropaste in Chest Masculinizing Surgery

NCT06428669 | Recruiting Phase 4 FDA Drug

• 1 other identifier: HSR220217
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Free Nipple Graft Take

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

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

• Wounds

  Rate of superficial wound, deep wound, delayed wound healing

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

Secondary Outcomes (4)

• Complications

  Will be tracked up until 3 months post-op

• Sharp debridement

  Will be tracked up until 3 months post-op

• Revision

  Will be tracked up until 3 months post-op

• Readmission

  Will be tracked 30 days

Study Arms (2)

No nitropaste group

NO 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 group

EXPERIMENTAL

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.

Drug: Nitro-Bid 2 % Topical Ointment

Interventions

Nitro-Bid 2 % Topical Ointment DRUG

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

Nitropaste group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Medical Center

Charlottesville, Virginia, 22902, United States

RECRUITING

Related Publications (1)

• Park RH, Pawly J, Grogan G, DeVito RG, Ke BG, Behar BJ, Stranix JT. Topical Nitropaste Reduces Partial Free Nipple Graft Loss in Gender Affirming Mastectomy: A Randomized Controlled Trial. Plast Reconstr Surg. 2026 Feb 2. doi: 10.1097/PRS.0000000000012874. Online ahead of print.

  PMID: 41628614 DERIVED

MeSH Terms

Conditions

Gender Dysphoria

Interventions

Nitroglycerin; Ointments

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• John T Stranix, MD

  UVA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel H Park, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Plastic Surgery

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: August 15, 2022
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)