Fat graft beneath penile skin graft during reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional trial compares standard penile reconstruction with and without a thin layer of autologous fat graft placed beneath a split-thickness skin graft. Participants undergo the same surgical procedure, with half receiving the fat graft and half receiving standard care alone, and are followed for 12 months to assess healing, pliability, and cosmetic outcomes. The fat grafting approach aims to enhance tissue coverage, potentially improve vascularity, reduce adhesions, and support restoration of penile contour. Outcomes are collected through outpatient visits and chart reviews. The study is led by the University of Pittsburgh at UPMC Mercy Hospital and investigates a novel, readily applicable adjunct to penile reconstruction.

Why it matters

Who can join: the full rules

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

Where it's running

• UPMC Mercy Hospital
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Paul J Rusilko, DO — University of Pittsburgh
• Study coordinator: Roger D Klein, MD, PhD
• Email: urologyresearch@upmc.edu
• Phone: 800-533-8762

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.