Clinical trial NCT06857448: Autologous Point-of-Care Adipose Therapy: Recent Injury
Official title: Autologous Point-of-Care Adipose Therapy for Reconstruction and Regeneration of Traumatized Skin: Recent Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Burns
Contracture Scar
Surgical Injury
Keywords: fasciotomy
trauma
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Armed Forces Institute of Regenerative Medicine
First posted: 2025-03-04
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

Detailed description: Soft-tissue injuries from blasts, burns, or multiple traumas can cause severe damage, leading to loss of function, lower quality of life, long recovery times, and inability to work. When these injuries involve deep burns or full-thickness tissue loss in areas that move a lot, they are especially difficult to treat due to the risk of scarring, stiffness, and tissue sticking together. There is a need for a reliable, single-stage treatment that can provide soft, flexible tissue reconstruction with minimal risk, cost, and, complexity. To address this issue, the investigators propose a fat-based approach to reconstruction. Fat tissue is easily available from the patient's own body and carries many benefits in reconstructive surgery. Our team has shown that using a layer of fat immediately in treatment creates a soft, vascular layer that reduces scarring, improves tissue volume, and supports a one-stage, multi-layer reconstruction without the need for complex surgery or causing harm to the donor area. The purpose of this study is to compare this reconstructive approach under the following conditions:

• Demonstrate efficacy of immediate autologous adipose and autologous layered Composite Grafting in acute functional soft-tissue reconstruction.

Evaluators including dedicated observers will be blinded to treatment group/strategy.

Eligibility criteria: Inclusion Criteria:

* 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.
* Additional inclusion criteria includes willingness to be randomized to receive a fat graft.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: From surgery to 9-month clinical endpoint.
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).
timeFrame: From surgery to 9-month clinical endpoint.
measure: Number of Operative Encounters
timeFrame: From surgery to 9-month clinical endpoint.
measure: Percent Graft Take
timeFrame: From surgery to 9-month clinical endpoint.
measure: Time to Final Healing/Graft Take
timeFrame: From surgery to 9-month clinical endpoint.
measure: Photographic Appearance of Wound
timeFrame: From surgery to 9-month clinical endpoint.
measure: Area of Wound
timeFrame: From surgery to 9-month clinical endpoint.
measure: Tissue Thickness
timeFrame: From surgery to 9-month clinical endpoint.
measure: Pliability (Tensiometry/Cutometry)
timeFrame: From surgery to 9-month clinical endpoint.
measure: Tissue Mobility (Resistance to Adhesion)
timeFrame: From surgery to 9-month clinical endpoint.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Mercy Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Presbyterian Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Francesco Egro
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.