Actively Recruiting
Microsurfaced Grafts in Deep Burn Wounds
Led by CellTherX · Updated on 2021-01-15
20
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed as a prospective, randomized, within subject controlled design to evaluate the effectiveness of Microsurfaced vs Control cadaveric grafts for coverage of acute deep-partial or full-thickness burn wounds to promote wound healing. This study will be performed in 2 parts: Time to wound bed preparedness through 6 weeks (Part A) and wound site healing, graft take and long-term scar outcomes (Part B). Subjects will be treated with both control and microsurfaced cadaveric grafts on adjacent deep-partial or full-thickness burn wounds.
CONDITIONS
Official Title
Microsurfaced Grafts in Deep Burn Wounds
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by patient or legally authorized representative
- Deep partial or full thickness burn injury from flame, scald, or contact burn
- Burn site large enough to place both control and microsurfaced grafts (minimum 4 cm2 each) on the same or two separate sites
- Total body surface area burned is 30% or less
- Admission to treatment within 72 hours of burn injury
- Non-infected wound at admission as diagnosed by physician
- Treated as outpatient or in observational setting
- Age 21 years or older
You will not qualify if you...
- Burns involving the face
- Burns caused by electrical, chemical, or frostbite injuries
- Admission to treatment more than 72 hours after injury
- Wounds infected at admission
- Pregnant or planning to become pregnant
- Nursing or actively lactating
- Developmental disability or significant psychological disorder impairing consent or participation, including untreated schizophrenia, bipolar disorder, or recent psychiatric hospitalization
- Active alcohol or substance abuse impairing study participation
- Any medical condition or co-morbidity preventing successful study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Joseph M Still Research Foundation
Augusta, Georgia, United States, 30909
Actively Recruiting
Research Team
J
Joan Wilson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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