Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
ID06428669

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

Led by University of Virginia · Updated on 2024-06-06

256

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating nitropaste, a topical agent containing 2% nitroglycerin known for its vascular dilating effects, to see if it can reduce wound complications in patients undergoing chest masculinizing surgery using the double incision and free nipple grafting technique. This study is a prospective, randomized, single-blinded trial designed to explore nitropaste's potential benefits in this surgical context, as previous research has shown its positive effects on flap survival and wound healing in other procedures. Participants will be randomly assigned to one of two groups: one receiving the standard chest masculinizing surgery with standard dressings only, and the other receiving the same surgery plus a one-time intraoperative application of 30 mg nitropaste (15 mg on each chest) around the nipple graft and surgical sites. Both groups will have standard dressings applied, including a Xeroform bolster and Tegaderm, which they will keep until postoperative day 5 when the bolster is removed. During the study, participants will be followed up at 5 days, 2 weeks, and 6 weeks after surgery during routine postoperative visits. Researchers will assess the condition of free nipple grafts and other wounds as the primary outcomes. They will also monitor secondary outcomes such as complications, need for sharp debridement, revision surgeries, and hospital readmissions up to three months post-operation. The study will document any events including hematoma, seroma, infection, hypertrophic scarring, and emergency visits within 30 days.

CONDITIONS

Brief Title

Effect of Nitropaste in Chest Masculinizing Surgery

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients 18 years or older
  • Undergoing chest masculinizing surgery using double incision and free nipple grafting
  • Any gender identity
Not Eligible

You will not qualify if you...

  • Younger than 18 years
  • Not undergoing free nipple grafting
  • Not using the double incision surgical pattern
  • Prisoners
  • Allergic to nitropaste
  • Taking phosphodiesterase inhibitors such as Sildenafil, tadalafil, or vardenafil
  • Taking soluble guanylate cyclase stimulator riociguatdz

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery day

Participants undergo chest masculinizing surgery with double incision and free nipple grafting. Nitropaste is applied once during surgery for those in the treatment group, while others receive standard care without nitropaste.

1 visit (in-person, surgery day)

Post-operative Follow-up

Duration - 6 weeks

Participants have follow-up visits to assess wound healing, free nipple graft condition, and monitor for any complications after surgery.

3 visits (post-op day 5, 2 weeks, and 6 weeks)

Follow-up

Duration - Up to 3 months post-op

Participants are monitored for any complications, need for sharp debridement, revisions, and readmissions up to 3 months after surgery.

Visits as part of routine care and monitoring

Trial Site Locations

Total: 1 location

1

University of Virginia Medical Center

Charlottesville, Virginia, United States, 22902

Actively Recruiting

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Research Team

R

Rachel H Park, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Topical Nitropaste Reduces Partial Free Nipple Graft Loss in Gender Affirming Mastectomy: A Randomized Controlled Trial.

Rachel H Park, Jessica Pawly, Graham Grogan...

https://pubmed.ncbi.nlm.nih.gov/41628614