StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

Study Overview
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Brief Summary
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About 20 participants will be enrolled in this trial if they have had an accident that damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their body. This condition is called full-thickness complex skin defects resulting from acute traumatic skin loss. Participants will be treated with StrataGraft skin tissue to evaluate it's safety and effectiveness for use in treating full-thickness complex skin defects.

Detailed Description
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The objective of this range-finding study was to assess the safety, tolerability, and efficacy of single or repeated application of StrataGraft skin tissue in full-thickness complex skin defects resulting from acute traumatic skin loss (eg, thermal burns or degloving injuries) requiring surgical excision and autografting.

Official Title
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Open-label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Single or Multiple Applications of StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

Conditions
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Trauma-related Wound, Burns, Skin Wound

Intervention / Treatment
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* Biological: StrataGraft Skin Tissue
* Procedure: Autograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged 18-65 years, inclusive Written informed consent Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting Complex skin defects of up to 49% Total Body Surface Area (TBSA) requiring excision and autografting Total skin defect may consist of more than one wound area Full-thickness complex skin defects requiring excision and autografting Study treatment sites on the torso and limbs may be up to 200 cm2 in cohort 1 and 400 cm2 in cohort 2 For thermal burns only, first excision and grafting of treatment sites Exclusion Criteria: Pregnant women and prisoners Subjects receiving systemic immunosuppressive therapy Subjects with a known history of malignancy Preadmission insulin-dependent diabetic subjects Subjects with concurrent conditions that in the opinion of the investigator may compromise subject safety or study objectives Expected survival of less than three months Participation in the treatment group of an interventional study within the 90 days prior to enrollment Chronic wounds The face, head, neck, hands, feet, buttocks, perineum, and area over joints Treatment sites with exposed tendon or bony prominences Chemical and electrical burns Treatment sites adjacent to unexcised eschar Clinical suspicion of infection at the anticipated treatment sites

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Intervention Model: Single Group Assignment
Interventional Model Description: See detailed description
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: StrataGraft skin tissue<br> | Biological: StrataGraft Skin Tissue<br>* StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).<br>Procedure: Autograft<br>* The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months | The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined. | 3 months | 
| Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months | Complete wound closure is defined as ≥95% re-epithelialization of all treatment sites with the absence of drainage | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months |  | within 3 months | 
| Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months |  | within 3, 6 and 12 months | 
| Percent Wound Closure at 3, 6, and 12 Months |  | within 3, 6, and 12 Months | 
| Cosmesis of Treatment Sites at 3, 6, and 12 Months | Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance | within 3, 6, and 12 Months | 
| Cosmesis of Donor Sites at 3, 6, and 12 Months | Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance | within 3, 6, and 12 Months | 
| Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28 |  | at days 3, 7, 14, 21, and 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Full-thickness, Acute trauma