RecruitingPhase 4NCT06428669

Effect of Nitropaste in Chest Masculinizing Surgery

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


Sponsor

University of Virginia

Enrollment

256 participants

Start Date

Aug 15, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria1

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

Exclusion Criteria6

  • 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

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Interventions

DRUGNitro-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(1)

University of Virginia Medical Center

Charlottesville, Virginia, United States

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NCT06428669


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