Autologous Point-of-Care Adipose Therapy: Recent Injury

NCT06857448 | Not Yet Recruiting

• 1 other identifier: STUDY24080150 - Recent Injury
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to explore if an adipose-based therapeutic strategy can treat full-thickness soft-tissue trauma wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are: \- Can immediate autologous adipose and autologous layered composite grafting be effective for acute functional soft-tissue reconstruction? 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 immediate fat grafting into the wound.
• Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.

Conditions

Burns; Contracture Scar; Surgical Injury

Keywords

fasciotomy; trauma

Outcome Measures

Primary Outcomes (1)

• 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.

  POSAS measures subjective assessment on a 1-10 scale from normal skin to worst scar imaginable across 6 metrics (surface area, vascularity, pigmentation, thickness, pliability and relief). The lowest sum score, reflecting normal skin, is 6 and the highest score, reflecting the worst imaginable scar, is 60.

  From surgery to 9-month clinical endpoint.

Secondary Outcomes (9)

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

  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.

• Photographic Appearance of Wound

  From surgery to 9-month clinical endpoint.

Study Arms (2)

Acute Split Thickness Skin Graft (STSG) Reconstruction

ACTIVE COMPARATOR

In this Arm, the investigators will evaluate full thickness defects generated after fasciotomy, trauma debridement, and/or burn excision of the face, neck, or extremities. These wounds represent common, full-thickness injuries, which require prolonged recovery and dressing changes as bridge to either skin graft or delayed closure and commonly are associated with contour irregularities, adhesions, and contracture. The investigators will assess current standard of care dressing changes followed by immediate STSG.

Procedure: Split Thickness Skin Graft (STSG)

Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).

EXPERIMENTAL

In this Arm, the investigators will evaluate full thickness defects generated after fasciotomy, trauma debridement, and/or burn excision of the face, neck, or extremities. These wounds represent common, full-thickness injuries, which require prolonged recovery and dressing changes as bridge to either skin graft or delayed closure and commonly are associated with contour irregularities, adhesions, and contracture. The investigators will assess current standard of care dressing changes followed by base of wound fat graft with STSG reconstruction (Autologous Layered Composite Grafting).

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

Interventions

Split Thickness Skin Graft (STSG) PROCEDURE

Partial thickness skin in STSGs are performed by harvesting via dermatome the donor site. Donor sites are typically taken from a flat surface on the thigh, lower back, or gluteal region to allow for a graft of even thickness and the selection of donor site is to be based on clinical standard practice. These grafts are placed on the prepared recipient site.

Acute Split Thickness Skin Graft (STSG) Reconstruction

Base of wound fat graft with 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.

Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).

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 unilateral or bilateral fasciotomy of the extremity at any level necessary
• secondary to non-infectious etiology,
• unilateral or bilateral traumatic full-thickness skin loss of the face, head, neck or extremities necessitating reconstruction, and/or
• full or partial thickness burn injury of the face, neck, or extremity requiring excision and/or reconstruction.

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; Wounds and Injuries

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

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 quality of acute reconstruction across two treatment arms after fasciotomy, trauma and/or burn defects (68 subjects). * Group 1: Split Thickness Skin Graft (STSG) 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)