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

NCT07316491 | Not Yet Recruiting

• 1 other identifier: STUDY25050015
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Penile Tissue Pliability

  The primary outcome of this study will be cutometric assessment of penile tissue pliability following split-thickness skin grafting. This will be measured using established noninvasive, nondestructive techniques that are not expected to cause significant discomfort or distress to patients. The numeric outcome of this, as measured in millimeters, will be directly compared between the experimental and active comparator arms. More pliability is manifested as increased pliability, as measured in millimeters.

  3 and 12 months postoperatively

Secondary Outcomes (8)

• Sexual Function

  Preoperatively, 3 months postoperatively, and 12 months postoperatively

• Urinary Function

  Preoperatively, 3 months postoperatively, and 12 months postoperatively

• Genital Self-Image

  Preoperatively, 3 months postoperatively, 12 months postoperatively

• Safety and Surgical Complications

  Immediately postoperatively through 12 months, including in-person visits at 7 days, 4 weeks, 3 months, and 12 months postoperatively. A telephone call will also be initiated 6 months postoperatively.

• Stretched Penile Length

  Intraoperatively, 3 months postoperatively, 12 months postoperatively

Study Arms (2)

STSG Alone

ACTIVE COMPARATOR

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.

Procedure: Genitourinary Reconstruction with Split-Thickness Skin Grafting

STSG with Autologous Fat Grafting

EXPERIMENTAL

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.

Procedure: Autologous fat grafting; Procedure: Genitourinary Reconstruction with Split-Thickness Skin Grafting

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.

STSG with Autologous Fat 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.

STSG Alone; STSG with Autologous Fat Grafting

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Mercy Hospital

Pittsburgh, Pennsylvania, 15219, United States

Location

Related Publications (17)

• Sivak WN, Ruane EJ, Hausman SJ, Rubin JP, Spiess AM. Decellularized Matrix and Supplemental Fat Grafting Leads to Regeneration following Traumatic Fingertip Amputation. Plast Reconstr Surg Glob Open. 2016 Oct 12;4(10):e1094. doi: 10.1097/GOX.0000000000001094. eCollection 2016 Oct.

  PMID: 27826486 BACKGROUND

• Bourne DA, Thomas RD, Bliley J, Haas G, Wyse A, Donnenberg A, Donnenberg VS, Chow I, Cooper R, Coleman S, Marra K, Pasquina PF, Rubin JP. Amputation-Site Soft-Tissue Restoration Using Adipose Stem Cell Therapy. Plast Reconstr Surg. 2018 Nov;142(5):1349-1352. doi: 10.1097/PRS.0000000000004889.

  PMID: 30511990 BACKGROUND

• Biyao Z, Gang X, Hai J, Chenwang D, Xuan L. Autologous fat grafting combined with negative pressure wound therapy in severe diabetic foot ulcer: a case study. J Wound Care. 2021 Apr 1;30(Sup4):S38-S40. doi: 10.12968/jowc.2021.30.Sup4.S38.

  PMID: 33856926 BACKGROUND

• Piccolo NS, Piccolo MS, Piccolo MT. Fat grafting for treatment of burns, burn scars, and other difficult wounds. Clin Plast Surg. 2015 Apr;42(2):263-83. doi: 10.1016/j.cps.2014.12.009. Epub 2015 Feb 21.

  PMID: 25827568 BACKGROUND

• Kenny EM, Egro FM, Ejaz A, Coleman SR, Greenberger JS, Rubin JP. Fat Grafting in Radiation-Induced Soft-Tissue Injury: A Narrative Review of the Clinical Evidence and Implications for Future Studies. Plast Reconstr Surg. 2021 Apr 1;147(4):819-838. doi: 10.1097/PRS.0000000000007705.

  PMID: 33776031 BACKGROUND

• Gentile P, Sterodimas A, Calabrese C, Garcovich S. Systematic review: Advances of fat tissue engineering as bioactive scaffold, bioactive material, and source for adipose-derived mesenchymal stem cells in wound and scar treatment. Stem Cell Res Ther. 2021 Jun 2;12(1):318. doi: 10.1186/s13287-021-02397-4.

  PMID: 34078470 BACKGROUND

• Dong J, Wu B, Tian W. Adipose tissue-derived small extracellular vesicles modulate macrophages to improve the homing of adipocyte precursors and endothelial cells in adipose tissue regeneration. Front Cell Dev Biol. 2022 Dec 6;10:1075233. doi: 10.3389/fcell.2022.1075233. eCollection 2022.

  PMID: 36561367 BACKGROUND

• Theisen KM, Fuller TW, Rusilko P. Surgical Management of Adult-acquired Buried Penis: Impact on Urinary and Sexual Quality of Life Outcomes. Urology. 2018 Jun;116:180-184. doi: 10.1016/j.urology.2018.03.031. Epub 2018 Apr 3.

  PMID: 29625136 BACKGROUND

• Seitz AJ, Edalatpour A, Israel JS, Grimes MD, Williams DH, Poore SO. Postoperative Outcomes following Buried Penis Reconstruction: A Single-Institution Experience Using the Wisconsin Classification System. Plast Reconstr Surg. 2024 May 1;153(5):1151-1160. doi: 10.1097/PRS.0000000000010868. Epub 2023 Jun 20.

  PMID: 37337329 BACKGROUND

• Staniorski CJ, Myrga JM, Vasan RV, Klein RD, Rusilko PJ. Surgical Outcomes and Prediction of Complications Following High-complexity Buried Penis Reconstruction. J Urol. 2023 Nov;210(5):782-790. doi: 10.1097/JU.0000000000003669. Epub 2023 Aug 16.

  PMID: 37586110 BACKGROUND

• Kara O, Teke K, Ciftci S, Ustuner M, Uslubas AK, Bosnali E, Culha MM. Buried penis in adults as a complication of circumcision: Surgical management and long-term outcomes. Andrologia. 2021 Mar;53(2):e13921. doi: 10.1111/and.13921. Epub 2020 Nov 26.

  PMID: 33244793 BACKGROUND

• Kumar T, Patel A, Chaffin AE. Use of Suprapubic Panniculus for Split-Thickness Skin Graft in Buried Penis Repair. Eplasty. 2024 Feb 6;24:e6. eCollection 2024.

  PMID: 38476520 BACKGROUND

• Flynn KJ, Vanni AJ, Breyer BN, Erickson BA. Adult-Acquired Buried Penis Classification and Surgical Management. Urol Clin North Am. 2022 Aug;49(3):479-493. doi: 10.1016/j.ucl.2022.04.009. Epub 2022 Jun 29.

  PMID: 35931438 BACKGROUND

• Falcone M, Preto M, Timpano M, Oderda M, Plamadeala N, Cirigliano L, Blecher G, Peretti F, Ferro I, Gontero P. The outcomes of surgical management options for adult acquired buried penis. Int J Impot Res. 2023 Dec;35(8):712-719. doi: 10.1038/s41443-022-00642-9. Epub 2022 Nov 18.

  PMID: 36400942 BACKGROUND

• Thornton SM, Seitz AJ, Edalatpour A, Poore SO. Surgical management of adult acquired buried penis syndrome: A systematic review of patient-reported outcome instruments. J Plast Reconstr Aesthet Surg. 2024 Apr;91:181-190. doi: 10.1016/j.bjps.2024.02.009. Epub 2024 Feb 6.

  PMID: 38422919 BACKGROUND

• Deptula P, Fox P. Autologous Fat Grafting in Hand Surgery. J Hand Surg Am. 2021 Jul;46(7):594-600. doi: 10.1016/j.jhsa.2021.02.015. Epub 2021 Apr 13.

  PMID: 33858716 BACKGROUND

• Kaur S, Rubin JP, Gusenoff J, Sommers CA, Shamsunder MG, Hume KM, Mehrara BJ. The General Registry of Autologous Fat Transfer: Concept, Design, and Analysis of Fat Grafting Complications. Plast Reconstr Surg. 2022 Jun 1;149(6):1118e-1129e. doi: 10.1097/PRS.0000000000009162. Epub 2022 Apr 11.

  PMID: 35404336 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Paul J Rusilko, DO

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roger D Klein, MD, PhD

CONTACT

800-533-8762; urologyresearch@upmc.edu

Michelle Lucas, MS

CONTACT

412-624-4708; mcmeansmm2@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Reconstructive Urology, Associate Professor of Urology

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 5, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)