Autologous Point-of-Care Adipose Therapy: Delayed Injury/Scar

NCT06857435 | Not Yet Recruiting

• 1 other identifier: STUDY24080150 - Delayed Injury
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to explore if an adipose-based therapeutic strategy can treat contracted scars secondary to soft-tissue burn wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are: \- Can autologous layered composite grafting demonstrate non-inferiority compared to full-thickness skin grafting for delayed reconstruction of post-burn or trauma scar contracture? Researchers will compare the single-stage autologous layered composite grafting method to traditional methods to see if it improves healing outcomes, minimizes scarring, and reduces infection risk. Participants will:

• Receive fat grafting at time of scar revision.
• Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.

Conditions

Burns; Contracture Scar; Surgical Injury

Keywords

burns; scar contracture

Outcome Measures

Primary Outcomes (1)

• Change in scar contracture, as measured by change in scar surface area size

  Contracture as measured by change in surface area of reconstruction between time of surgery and 9-month clinical endpoint/maturation of reconstruction. These data will be derived by serial photography.

  From surgery to 9-month clinical endpoint.

Secondary Outcomes (8)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).

  From surgery to 9-month clinical endpoint.

• Total score on the Patient and Observer Scar Assessment Scale (POSAS): Pigmentation, Pliability, Vascularity, Thickness, Relief, and Surface Area, collected at the 9 month follow up visit. Remove

  From surgery to 9-month clinical endpoint.

• Number of Operative Encounters

  From surgery to 9-month clinical endpoint.

• Percent Graft Take

  From surgery to 9-month clinical endpoint.

• Time to Final Healing/Graft Take

  From surgery to 9-month clinical endpoint.

Study Arms (2)

Delayed Full Thickness Skin Graft (FTSG) Reconstruction

ACTIVE COMPARATOR

In this Arm, the investigators will assess FTSGs for reconstruction of defects after burn scar revision of the face, neck, or extremities. Participants will receive any release and/or preparation of the scar/wound bed as would be standard of care and will then receive reconstruction with a FTSG.

Procedure: Full Thickness Skin Graft (FTSG)

Delayed Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Graft)

EXPERIMENTAL

In this Arm, the investigators will assess Autologous Layered Composite Grafting for reconstruction of defects after burn scar revision of the face, neck, or extremities. Participants will receive any release and/or preparation of the scar/wound bed as would be standard of care and will then receive reconstruction with a Autologous Layered Composite Graft.

Procedure: Base of wound fat graft with Split Thickness Skin Graft (STSG) Reconstruction (Autologous Layered Composite Grafting).

Interventions

Full Thickness Skin Graft (FTSG) PROCEDURE

Full thickness skin in FTSGs are harvested by different means by surgeon preference and standard of care. Typically an area of skin with matching color and texture to the site which needs reconstruction is identified from a hidden and/or non-cosmetic area and collected via excision. After excision the donor site is closed and the graft is thinned by using a scalpel or scissors to remove excess fat or other soft tissues from the deep surface before being placed in the donor site.

Delayed Full Thickness Skin Graft (FTSG) Reconstruction

Base of wound fat graft with Split Thickness Skin Graft (STSG) Reconstruction (Autologous Layered Composite Grafting). PROCEDURE

Autologous Layered Composite Grafting consists of the layered strategy of simultaneous fat and skin grafting. Fat is harvested by minimally invasive liposuction and applied directly to the wound base without any chemical or biologic processing. Skin is harvested as a split thickness skin graft by dermatome and applied over the layer of adipose tissue.

Delayed Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Graft)

Eligibility Criteria

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

You may qualify if:

• The proposed study will include adult patients 18 years of age or older,
• male or female,
• civilian, military, active duty or retired veterans
• presenting for scar contracture release and reconstruction at any level.

You may not qualify if:

• Age \< 18 years of age,
• active infection,
• medical co-morbidities or anatomic configuration deemed by the physician to be a concern for safety,
• unwilling or unable to comply with study procedures,
• radiation to the site of interest,
• prisoners and/or vulnerable populations.
• In addition, candidates that are pregnant or plan to become pregnant in the next year, will be excluded.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Armed Forces Institute of Regenerative Medicine: collaborator

Study Sites (2)

Mercy Hospital

Pittsburgh, Pennsylvania, 15219, United States

Location

Presbyterian Hospital

Pittsburgh, Pennsylvania, 15219, United States

Location

Related Publications (11)

• 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

• Simonacci F, Bertozzi N, Grieco MP, Grignaffini E, Raposio E. Procedure, applications, and outcomes of autologous fat grafting. Ann Med Surg (Lond). 2017 Jun 27;20:49-60. doi: 10.1016/j.amsu.2017.06.059. eCollection 2017 Aug.

  PMID: 28702187 BACKGROUND

• Evans BGA, Gronet EM, Saint-Cyr MH. How Fat Grafting Works. Plast Reconstr Surg Glob Open. 2020 Jul 14;8(7):e2705. doi: 10.1097/GOX.0000000000002705. eCollection 2020 Jul.

  PMID: 32802628 BACKGROUND

• Woodruff SI, Galarneau MR, McCabe CT, Sack DI, Clouser MC. Health-related quality of life among US military personnel injured in combat: findings from the Wounded Warrior Recovery Project. Qual Life Res. 2018 May;27(5):1393-1402. doi: 10.1007/s11136-018-1806-7. Epub 2018 Feb 15.

  PMID: 29450855 BACKGROUND

• Mokos ZB, Jovic A, Grgurevic L, Dumic-Cule I, Kostovic K, Ceovic R, Marinovic B. Current Therapeutic Approach to Hypertrophic Scars. Front Med (Lausanne). 2017 Jun 20;4:83. doi: 10.3389/fmed.2017.00083. eCollection 2017.

  PMID: 28676850 BACKGROUND

• Finnerty CC, Jeschke MG, Branski LK, Barret JP, Dziewulski P, Herndon DN. Hypertrophic scarring: the greatest unmet challenge after burn injury. Lancet. 2016 Oct 1;388(10052):1427-1436. doi: 10.1016/S0140-6736(16)31406-4.

  PMID: 27707499 BACKGROUND

• Marshall CD, Hu MS, Leavitt T, Barnes LA, Lorenz HP, Longaker MT. Cutaneous Scarring: Basic Science, Current Treatments, and Future Directions. Adv Wound Care (New Rochelle). 2018 Feb 1;7(2):29-45. doi: 10.1089/wound.2016.0696.

  PMID: 29392092 BACKGROUND

• Wolf JM, Athwal GS, Shin AY, Dennison DG. Acute trauma to the upper extremity: what to do and when to do it. Instr Course Lect. 2010;59:525-38.

  PMID: 20415403 BACKGROUND

• Harrison BL, Lakhiani C, Lee MR, Saint-Cyr M. Timing of traumatic upper extremity free flap reconstruction: a systematic review and progress report. Plast Reconstr Surg. 2013 Sep;132(3):591-596. doi: 10.1097/PRS.0b013e31829ad012.

  PMID: 23676968 BACKGROUND

• Le TD, Gurney JM, Nnamani NS, Gross KR, Chung KK, Stockinger ZT, Nessen SC, Pusateri AE, Akers KS. A 12-Year Analysis of Nonbattle Injury Among US Service Members Deployed to Iraq and Afghanistan. JAMA Surg. 2018 Sep 1;153(9):800-807. doi: 10.1001/jamasurg.2018.1166.

  PMID: 29847675 BACKGROUND

• D'Souza EW, MacGregor AJ, Dougherty AL, Olson AS, Champion HR, Galarneau MR. Combat injury profiles among U.S. military personnel who survived serious wounds in Iraq and Afghanistan: A latent class analysis. PLoS One. 2022 Apr 6;17(4):e0266588. doi: 10.1371/journal.pone.0266588. eCollection 2022.

  PMID: 35385552 BACKGROUND

MeSH Terms

Conditions

Burns; Intraoperative Complications

Interventions

Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Francesco Egro

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleanor Shirley

CONTACT

412-641-8676; shirleye@upmc.edu

Patsy Simon

CONTACT

412-641-8676; simopa@UPMC.EDU

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Burn Reconstruction

Model Details: Autologous Layered Composite Grafting consists of the layered strategy of simultaneous fat and skin grafting. Fat is harvested by minimally invasive liposuction and applied directly to the wound base without any chemical or biologic processing. Skin is harvested as per standard of care and applied either to the wound bed directly as per controls or to the layer of adipose tissue. Investigators will compare delayed reconstruction of scar contracture across two treatment arms (40 subjects). * Group 1: Full thickness skin graft (FTSG) Reconstruction; * Group 2: Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: March 4, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)