Effect of Nitropaste in Chest Masculinizing Surgery

University of Virginia

Status and phase: Enrolling; Phase 4

Conditions: Gender Dysphoria

Treatments: Drug: Nitro-Bid 2 % Topical Ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT06428669

HSR220217

Details and patient eligibility

About

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.

Full 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.

Enrollment: 256 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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256 participants in 2 patient groups

No nitropaste group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Drug: Nitro-Bid 2 % Topical Ointment