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

Conditions

• Adult-Acquired Buried Penis
• Penile Skin
• Penis/Injuries
• Penis/Surgery

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Autologous fat grafting — PROCEDURE
  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 — PROCEDURE
  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.

Study Details

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 Dates

Start date

Jun 1, 2026

Status verified

Apr 2026

Primary completion

Mar 1, 2028

Completion

Mar 1, 2028

Study Design

Enrollment

24 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Roger D Klein, MD, PhD
  800-533-8762
  [email protected]
• Michelle Lucas, MS
  412-624-4708
  [email protected]

Locations (1)

Find similar trials in Pittsburgh, PA

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