Effect of Nitropaste in Chest Masculinizing Surgery

Gender Dysphoria Clinical Trial

Official title:

The Effect of Nitropaste in Chest Masculinizing Surgery: Randomized, Prospective Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06428669
• Other study ID #: HSR220217
• Status: Recruiting
• Phase: Phase 4
• Start date: August 15, 2022
• Est. completion date: November 2025

Study information

• Verified date: June 2024
• Source: University of Virginia
• Contact: Rachel H Park, MD
• Phone: 434-327-2140
• Email: rhp7gu[@]hscmail.mcc.virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 utilizing double incision with free nipple grafting technique. The investigators will conduct a prospective, randomized, single-blinded study and compare nitropaste vs. no nitropaste on mastectomy flaps. Nitropaste will be applied intraoperatively and the patients will not have to re-apply it. Follow up will occur on post-op day 5, 2 weeks, and 6 weeks during their routine postop visits. A study coordinator will document the condition of free nipple grafts and any other wounds at surgical site if present, which will be the primary outcome. Any complications including hematoma, seroma, infection, hypertrophic scarring, need for sharp debridement, 30 day ED visit or admission rates will be documented as secondary outcome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: November 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Gender Dysphoria

Intervention

Drug:
• Nitro-Bid 2 % Topical Ointment
Intervention group will get 30mg of Nitro-Bid topical ointment applied over the chest (15mg/ 1 packet on each side) one time intra-operatively

Locations

Country	Name	City	State
United States	University of Virginia Medical Center	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Wounds	Rate of superficial wound, deep wound, delayed wound healing	Will be assessed at 5 days, 2 weeks, 6 weeks post-op
Secondary	Complications	hematoma, seroma, infection, hypertrophic scarring	Will be tracked up until 3 months post-op
Secondary	Sharp debridement	Need for any sharp debridement (office or OR)	Will be tracked up until 3 months post-op
Secondary	Revision	Need for any revision	Will be tracked up until 3 months post-op
Secondary	Readmission	30 day ED or inpatient admission rate	Will be tracked 30 days