Joseph M Still Research Foundation
Augusta, Georgia, 30909, United States
Location status: Recruiting
NCT Number: NCT04589442
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.
Interested in participating?
Request Info21 year and older
All sexes
Interventional
Phase 4
Augusta, Georgia, 30909, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
standard of care graft
standard of care graft that has been microsurfaced
Time frame: 6 week
To compare wound bed preparedness/time to autograft in deep-partial and full thickness burns and burn wound healing in partial thickness burns in burn sites treated with Microsurfaced vs Control cadaveric graft-treated groups through 6 weeks post initial injury.
Time frame: Through 12 months
Incidence of Infection at each treatment study visit
Time frame: 2 weeks
Autograft take will be documented as a percentage of the graft by the physician
Time frame: 2 weeks
Tissue oxygenation will be assessed using hyperspectral imaging
Time frame: 6 weeks
Change in tissue oxygenation at study burn site at the time of autografting as compared to baseline.
Time frame: 3, 6, 9, 12 months
Scar will be assessed using the Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 3, 6, 9, 12 months
Tissue oxygenation will be assessed using hyperspectral imaging
Contact information is provided by the study sponsor or research team.
CellTherX
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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