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

Not Applicable

Not yet recruiting

• Conditions: Burns; Contracture Scar; Surgical Injury

• Registration Number: NCT06857435
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-26
• Status Verified: 2025-03
• Study First Posted: 2025-03-04
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-19
• Study Start: 2025-06-30
• Primary Completion: 2028-01-31
• Study Completion: 2028-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in scar contracture, as measured by change in scar surface area size	From surgery to 9-month clinical endpoint.	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).	From surgery to 9-month clinical endpoint.	Incidence of adverse events will be reported for all study participants.
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.	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.
Number of Operative Encounters	From surgery to 9-month clinical endpoint.	The investigators will additionally assess early outcome metrics including number of operative encounters.
Percent Graft Take	From surgery to 9-month clinical endpoint.	The investigators will additionally assess early outcome metrics including percent graft take (% of surface area).
Time to Final Healing/Graft Take	From surgery to 9-month clinical endpoint.	The investigators will additionally assess early outcome metrics including, time to final healing/graft take in days.
Tissue Thickness	From surgery to 9-month clinical endpoint.	The investigators will measure tissue thickness as determined by ultrasound.
Pliability (Tensiometry/Cutometry)	From surgery to 9-month clinical endpoint.	The investigators will utilize a noninvasive cutometer/tensiometer to determine tissue pliability.
Tissue Adhesion/Mobility	From surgery to 9-month clinical endpoint.	The investigators will measure tissue mobility/resistance to adhesion under non-invasive tissue stretch.

Trial Locations

Locations (2)

Mercy Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Presbyterian Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States