Burns, Contracture Scar, Surgical Injury
Conditions
Keywords
fasciotomy, trauma
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.
Interventions
PROCEDURESplit Thickness Skin Graft (STSG)
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.
PROCEDUREBase of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).
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.
Sponsors
University of Pittsburgh
Armed Forces Institute of Regenerative Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Photographic Appearance of Wound | From surgery to 9-month clinical endpoint. | Photographic evaluation for wound appearance. This is gross appearance. |
| Area of Wound | From surgery to 9-month clinical endpoint. | Photographic evaluation for size of wound area. This is measured in cm2 |
| 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 Mobility (Resistance to Adhesion) | From surgery to 9-month clinical endpoint. | The investigators will measure tissue mobility under non-invasive tissue stretch. Measurement is achieved by the mm of stretch achievable from a given point under a standardized stress. |
Countries
United States
Contacts
CONTACTEleanor Shirley
CONTACTPatsy Simon
PRINCIPAL_INVESTIGATORFrancesco Egro
University of Pittsburgh
Outcome results
None listed