Clinical Trial

Autologous Fat Grafting Beneath Penile Split Thickness Skin Graft Placement During Penile Reconstruction

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Summary
The goal of this randomized interventional clinical trial is to learn if placement of a thin layer of fatty tissue (fat graft) beneath a split-thickness skin graft on the surface of the penis improved outcomes of surgery in men who are scheduled to undergo reconstructive surgery on their penis and genitals. This is a randomized study, meaning that half of participants will receive the fat graft with their standard-of-care surgery, and half will have their standard-of-care surgery alone. Fat grafting underneath split-thickness skin grafts in other parts of the body has been shown to improve healing of the skin graft. Both study groups will be followed for specific outcomes through outpatient clinic visits for the first 12 months after their surgery, as well as chart review. Questions the investigators hope to answer include: * Does fat grafting improve the pliability and feel of the penile skin after grafting * Does fat grafting change the penile length after surgery * Does fat grafting improve sexual function, urinary function, and genital self-image after surgery * Are there any unforeseen complications related to the fat grafting procedure Participants will be asked to complete questionnaires related to sexual, urinary, and genital self-image questionnaires before surgery, 3 months after surgery, and 12 months after surgery. Noninvasive testing of the penile skin will also be performed at participants' routine appointments.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-12-18; most recent amendment 2026-04-28.
Trial Details
NCT Number NCT07316491
Lead Sponsor University of Pittsburgh
Conditions Penis/Surgery, Penis/Injuries, Penile Skin, Adult-Acquired Buried Penis
Enrollment 24 participants
Start Date 2026-06-01
Primary Completion 2028-03-01 (estimated)
Study Completion 2028-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-05