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/41628614Actively Recruiting
Led by University of Virginia · Updated on 2024-06-06
256
Participants Needed
1
Research Sites
13 weeks
Total Duration
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
Effect of Nitropaste in Chest Masculinizing Surgery
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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)
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
Total: 1 location
1
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22902
Actively Recruiting
R
Rachel H Park, MD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Rachel H Park, Jessica Pawly, Graham Grogan...
https://pubmed.ncbi.nlm.nih.gov/41628614