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Procedure
Autologous Point-of-Care Adipose Therapy: Recent Injury
Pittsburgh, PA
N/A
Waitlist Available
Led By Francesco Egro
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* The proposed study will include adult patients 18 years of age or older
* male or female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from surgery to 9-month clinical endpoint.
Awards & highlights
No Placebo-Only Group
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.
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Who is the study for?
This trial is for individuals with full-thickness soft-tissue trauma, such as severe burns or significant tissue loss. Participants should have recent injuries that might benefit from advanced wound healing techniques. The study excludes those who may not be suitable due to specific medical conditions or factors determined by the researchers.Check my eligibility
What is being tested?
The study tests a new method of wound treatment using patients' own fat (autologous adipose) combined with skin grafting (Autologous Layered Composite Grafting). It compares this single-stage procedure against traditional methods to assess improvements in healing, scarring reduction, and infection prevention.See study design
What are the potential side effects?
Potential side effects could include pain at the fat donation site, complications related to skin grafting like infection or poor graft take, increased scarring despite efforts to minimize it, and other typical risks associated with surgical procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
* The proposed study will include adult patients 18 years of age or older
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* male or female
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* civilian, military, active duty or retired veterans
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* presenting for unilateral or bilateral fasciotomy of the extremity at any level necessary
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* secondary to non-infectious etiology
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* 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.
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* Additional inclusion criteria includes willingness to be randomized to receive a fat graft.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from surgery to 9-month clinical endpoint.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from surgery to 9-month clinical endpoint.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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.
Secondary study objectives
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).
Number of Operative Encounters
Percent Graft Take
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).Experimental Treatment1 Intervention
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).
Group II: Acute Split Thickness Skin Graft (STSG) ReconstructionActive Control1 Intervention
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.
Find a Location
Closest Location:Mercy Hospital· Pittsburgh, PA· 974 miles
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,815 Previous Clinical Trials
16,364,128 Total Patients Enrolled
2 Trials studying Burns
55 Patients Enrolled for Burns
Armed Forces Institute of Regenerative MedicineFED
6 Previous Clinical Trials
154 Total Patients Enrolled
1 Trials studying Burns
40 Patients Enrolled for Burns
Francesco EgroPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Burns
40 Patients Enrolled for Burns