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

Starting soon · Not applicable

Conditions studied: Penis/Surgery, Penis/Injuries, Penile Skin, Adult-Acquired Buried Penis

In brief

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.

Key facts

Study ID

NCT07316491

Run by

University of Pittsburgh

People needed

24

Starts

2026-06-01

Expected to finish

2028-03-01

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UPMC Mercy Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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