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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
standard of care graft
standard of care graft that has been microsurfaced
Joseph M Still Research Foundation
Augusta, Georgia, United States
RECRUITINGWound bed prep
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: 6 week
Infection
Incidence of Infection at each treatment study visit
Time frame: Through 12 months
Autograft take
Autograft take will be documented as a percentage of the graft by the physician
Time frame: 2 weeks
Tissue oxygenation
Tissue oxygenation will be assessed using hyperspectral imaging
Time frame: 2 weeks
Tissue Oxygenation
Change in tissue oxygenation at study burn site at the time of autografting as compared to baseline.
Time frame: 6 weeks
Scar assessment
Scar will be assessed using the Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 3, 6, 9, 12 months
Tissue oxygenation
Tissue oxygenation will be assessed using hyperspectral imaging
Time frame: 3, 6, 9, 12 months
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