NCT07316491 Autologous Fat Grafting Beneath Penile Split Thickness Skin Graft Placement During Penile Reconstruction
| NCT ID | NCT07316491 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Penis/Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-09-15 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2026-09-15 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Ability to participate in informed consent * Loss of penile skin necessitating split-thickness skin grafting for reconstruction * Willingness to undergo the study interventions and comply with required study procedures * Is a medical and surgical candidate to undergo standard-of-care split-thickness skin graft reconstruction of the penis after standard preoperative optimization Exclusion Criteria: * History of neophallus creation * A diagnosed disorder of connective tissue or collagen deposition/formation * The inability to obtain sufficient fat from the surgical specimen or separate lipoharvest donor site to allow the autologous fat tissue processing * Any medical condition that would preclude safe conduct of the lipoharvest and/or injection procedure per investigator discretion
Contact & Investigator
Paul J Rusilko, DO
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT07316491 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Penis/Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07316491 currently recruiting?
Yes, NCT07316491 is actively recruiting participants. Contact the research team at urologyresearch@upmc.edu for enrollment information.
Where is the NCT07316491 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT07316491 clinical trial?
NCT07316491 is sponsored by University of Pittsburgh. The principal investigator is Paul J Rusilko, DO at University of Pittsburgh. The trial plans to enroll 24 participants.