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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Pittsburgh

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Autologous fat grafting
  • Genitourinary Reconstruction with Split-Thickness Skin Grafting

Treatment groups

24 Participants
are divided into 2 treatment groups

Sponsors and collaborators