StrataGraft® Skin Tissue Expanded Access at Specific Study Sites ( StrataCAT )

Study Overview
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Brief Summary
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An autograft is a piece of skin taken from a healthy area of the body to be used to treat severe burns on another part of the same body. StrataGraft skin tissue was an investigational tissue that could be used as an alternative to an autograft. StrataGraft skin tissue was in late-stage clinical development for the treatment of adults with deep partial-thickness (DPT) burns. There were no safety concerns reported to date. The sponsor submitted a treatment protocol to Food and Drug Administration (FDA) for doctors who participated in the Phase 3 Strata 2016 study (NCT 03005106) to allow for expanded access to StrataGraft before it was commercially available. The main purpose of the study was to allow patients to receive StrataGraft during Biologics License Application review and prior to approval by the FDA for the treatment of DPT burns. The primary outcome measure was the number of participants with adverse events and safety concerns.

Detailed Description
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The primary purpose of this trial was to provide expanded access to StrataGraft for thermally induced DPT burns that contained intact dermal elements and for which surgical excision and autograft would normally be part of the clinical management.

Official Title
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A Multicenter, Open-label, Study of StrataGraft® Skin Tissue in Adult Subjects With Deep Partial-Thickness Thermal Burns

Conditions
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Deep Partial-thickness Burn

Intervention / Treatment
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* Biological: StrataGraft skin tissue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be considered for inclusion, a participant must: Provide written informed consent Have enough healthy skin to reserve as donor site(s), in case autografting becomes necessary Have protocol-defined thermal burn(s) on the torso, upper extremities and lower extremities: that are the right size for treatment areas, with intact dermal elements for which excision and autografting are clinically indicated, and have not been previously excised and grafted. Exclusion Criteria: A participant must be excluded from participation if he/she: Is pregnant, a prisoner, or expected to live less than 3 months Has any other condition that, per protocol or in the opinion of the investigator, may compromise the participant's safety or the study objectives Has participated in an investigational study within 90 days before enrollment

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: StrataGraft<br>On Day 1, participants received a single application of up to 1:1 meshed StrataGraft skin tissue on up to 3 DPT wound(s) totaling no more than approximately 2000 square centimeters (cm^2) in area. | Biological: StrataGraft skin tissue<br>* StrataGraft skin tissue was delivered as a single topical application to no more than 3 separate burn sites, totaling up to approximately 2000 cm^2 of treatment area using no more than 20 tissues.<br>* Other names: Experimental skin tissue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. A TEAE is defined as an adverse event that started on or after the start of treatment (i.e. placement of StrataGraft). | AEs were collected on each individual participant for the duration of their study participation, i.e. from the time of signing the informed consent until study completion (up to approximately 7 months). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alternative to Autograft