A Prospective, Randomized Study to Evaluate the Effectiveness of Microsurfaced vs Control Cadaveric Decellularized Grafts to Establish Wound Bed Preparedness in Deep Partial and Full Thickness Burn Wounds
CellTherX
Summary
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.
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Signed informed consent by patient or Legally Authorized Representative (LAR) * Subject with deep partial or full thickness burn injury due to flame burn, scald injury or contact burn * Study burn site large enough to accommodate placement of control and microsurfaced cadaveric graft (minimum 4 cm2 each) at the same location OR 2 study burn sites large enough to each accommodate control and microsurfaced cadaveric graft, respectively at minimum 4 cm2. * Total Body Surface Area burned (TBSA) total ≤30 % * Admission within 72 hours of burn injury * Non-infected wound as di…
Interventions
- BiologicalSplit thickness skin graft
standard of care graft
- Biologicalmicrosurfaced split thickness skin graft
standard of care graft that has been microsurfaced
Location
- Joseph M Still Research FoundationAugusta, Georgia