Clinical trial NCT06428669: Effect of Nitropaste in Chest Masculinizing Surgery
Official title: The Effect of Nitropaste in Chest Masculinizing Surgery: Randomized, Prospective Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Gender Dysphoria
Keywords: Gender affirming surgery
Chest masculinizing Surgery
Nitropaste
Wound healing
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 256
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Free Nipple Graft Take
timeFrame: Will be assessed at 5 days, 2 weeks, 6 weeks post-op
measure: Wounds
timeFrame: Will be assessed at 5 days, 2 weeks, 6 weeks post-op
Secondary outcomes:
measure: Complications
timeFrame: Will be tracked up until 3 months post-op
measure: Sharp debridement
timeFrame: Will be tracked up until 3 months post-op
measure: Revision
timeFrame: Will be tracked up until 3 months post-op
measure: Readmission
timeFrame: Will be tracked 30 days
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
Study officials:
affiliation: UVA
name: John T Stranix, MD
role: PRINCIPAL_INVESTIGATOR
References: