Effect of Nitropaste in Chest Masculinizing Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Gender Dysphoria
• Intervention / Treatment: Drug: Nitro-Bid 2 % Topical Ointment

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rachel H Park, MD; Phone Number: 434-327-2140; Email: rhp7gu@hscmail.mcc.virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22902
      • Recruiting
      • University of Virginia Medical Center
      • Contact: Rachel H Park, MD; Phone Number: 571-428-7278; Email: rhp7gu@hscmail.mcc.virginia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No nitropaste group; 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.
Experimental: Nitropaste group; 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; Intervention group will get 30mg of Nitro-Bid topical ointment applied over the chest (15mg/ 1 packet on each side) one time intra-operatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	hematoma, seroma, infection, hypertrophic scarring	Will be tracked up until 3 months post-op
Sharp debridement	Need for any sharp debridement (office or OR)	Will be tracked up until 3 months post-op
Revision	Need for any revision	Will be tracked up until 3 months post-op
Readmission	30 day ED or inpatient admission rate	Will be tracked 30 days

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: John T Stranix, MD, UVA

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Wound healing; Gender affirming surgery; Chest masculinizing Surgery; Nitropaste
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Gender Dysphoria; Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: HSR220217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes