Recruiting

Fat Grafting

Sponsor:

University of Pittsburgh

Code:

NCT07316491

Conditions

Penis/Surgery

Penis/Injuries

Penile Skin

Adult-Acquired Buried Penis

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Autologous fat grafting

Genitourinary Reconstruction with Split-Thickness Skin Grafting

Study Details

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.

Conditions

Penis/Surgery

Penis/Injuries

Penile Skin

Adult-Acquired Buried Penis

Study ID

NCT07316491

Start date

Sep 15, 2026

Status verified date

Sep, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: STSG Alone

Subjects randomized to this arm of the study will undergo standard-of-care split-thickness skin grafting of their penis without autologous fat grafting. They will undergo the same pre- and post-operative monitoring and complete the same testing as those in the experimental arm of the study.

experimental: STSG with Autologous Fat Grafting

Subjects randomized to this arm of the study will undergo standard-of-care split-thickness skin grafting of their penis with autologous fat grafting. For subjects from whom a sufficient quantity of healthy adipose tissue is excised as part of the standard-of-care reconstructive surgery they have elected to undergo, the autologous fat graft will be processed from this specimen and placed between the skin graft and fascia of the penis. For subjects from whom a sufficient quantity of healthy adipose tissue is not excised as part of their standard-of-care reconstructive surgery, lipoaspiration (liposuction) will be performed to harvest fatty tissue that will subsequently undergo minimal processing for grafting.

Interventions

Autologous fat grafting

In this intervention, subjects will undergo their standard-of-care reconstructive urologic surgery with penile split-thickness skin grafting as medically indicated for treatment of their underline penile/genitourinary condition(s). In addition to this reconstruction, autologous fat grafting will be performed beneath their penile skin graft. For subjects from whom a sufficient quantity of healthy adipose tissue is excised as part of the standard-of-care reconstructive surgery they have elected to undergo, the autologous fat graft will be processed from this specimen and placed between the skin graft and fascia of the penis. For subjects from whom a sufficient quantity of healthy adipose tissue is not excised as part of their standard-of-care reconstructive surgery, lipoaspiration (liposuction) will be performed to harvest fatty tissue that will subsequently undergo minimal processing for grafting.

Genitourinary Reconstruction with Split-Thickness Skin Grafting

Subject eligibility for this study is contingent upon a baseline disease process in which subjects require and are appropriate for genitourinary reconstruction with penile split-thickness skin grafting as their surgical standard of care. Patients in both arms will receive the standard of care reconstruction and split-thickness skin grafting. The donor site for the split-thickness skin graft with be at the discretion of the operating surgeon during the case and will not be affected by enrollment and/or allocation within the trial.

Primary outcome measure

  • Penile Tissue Pliability [ Time Frame: 3 and 12 months postoperatively ]

Central Contacts and Locations

Central contacts

Roger D Klein, MD, PhD

800-533-8762urologyresearch@upmc.edu

Locations

UPMC Mercy Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Contacts

Asif Shaik, MS

shaika@upmc.edu

Eleanor Shirley, MA, CCRC

shirleye@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Oct 22, 2026

Last verified

Sep, 2026

Keywords

  • Split-Thickness Skin Grafting
  • Autologous Fat Grafting
  • Penile Reconstruction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.