Microsurfaced Grafts in Deep Burn Wounds

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Burns, Wound Heal

Intervention / Treatment
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* Biological: Split thickness skin graft
* Biological: microsurfaced split thickness skin graft


Participation Criteria
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Eligibility Criteria
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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 diagnosed by the attending physician upon admission Treated as an outpatient or in an observational setting 21 years of age or older Exclusion Criteria: Burns involving the face Causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite) Admission time greater than 72 hours after the injury Wounds noted to be infected at admission Is pregnant or plans to become pregnant Is nursing or actively lactating Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years. Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's participation in the study protocol or record study materials Any medical condition or co-morbidity that in the opinion of the investigator, would prevent successful participation in the study

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care Dermal Graft<br>Standard of care cryopreserved cadaveric split thickness skin grafts | Biological: Split thickness skin graft<br>* standard of care graft<br>|
| Experimental: Standard of Care Dermal Graft - Microsurfaced<br>Microsurfaced cryopreserved cadaveric split thickness skin grafts | Biological: microsurfaced split thickness skin graft<br>* standard of care graft that has been microsurfaced<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound 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. | 6 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection | Incidence of Infection at each treatment study visit | Through 12 months | 
| Autograft take | Autograft take will be documented as a percentage of the graft by the physician | 2 weeks | 
| Tissue oxygenation | Tissue oxygenation will be assessed using hyperspectral imaging | 2 weeks | 
| Tissue Oxygenation | Change in tissue oxygenation at study burn site at the time of autografting as compared to baseline. | 6 weeks | 
| Scar assessment | Scar will be assessed using the Patient and Observer Scar Assessment Scale (POSAS) | 3, 6, 9, 12 months | 
| Tissue oxygenation | Tissue oxygenation will be assessed using hyperspectral imaging | 3, 6, 9, 12 months |