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New treatment option for Burns
Official title Autologous Point-of-Care Adipose Therapy: Recent Injury
ClinicalTrials.gov ID: NCT06857448
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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,
You likely can't join if
- 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.
See the full eligibility 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 includes willingness to be assigned by chance to receive a fat graft.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.