Clinical trial NCT06857435: Autologous Point-of-Care Adipose Therapy: Delayed Injury/Scar
Official title: Autologous Point-of-Care Adipose Therapy for Reconstruction and Regeneration of Traumatized Skin: Delayed Injury/Scar
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Burns
Contracture Scar
Surgical Injury
Keywords: burns
scar contracture
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Armed Forces Institute of Regenerative Medicine
First posted: 2025-03-04
Enrollment: 40
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 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).
Primary purpose: TREATMENT

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.

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 non-inferiority of autologous layered composite grafting to full-thickness skin grafting for delayed reconstruction of post-burn/trauma scar contracture.

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 scar contracture release and reconstruction at any level.
* 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: Change in scar contracture, as measured by change in scar surface area size
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: 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
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: Tissue Thickness
timeFrame: From surgery to 9-month clinical endpoint.
measure: Pliability (Tensiometry/Cutometry)
timeFrame: From surgery to 9-month clinical endpoint.
measure: Tissue Adhesion/Mobility
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:
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