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

Phase 3

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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:
1. that are the right size for treatment areas,
2. with intact dermal elements for which excision and autografting are clinically indicated, and
3. 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

Arm && Interventions

Group	Intervention	Description
StrataGraft	StrataGraft skin tissue	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	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).	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).

Secondary Outcome Measures

Name	Time	Method

Locations (10): MedStar Health Research Institute
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Washington, District of Columbia, United States
University Medical Center New Orleans
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New Orleans, Louisiana, United States
University of California Irvine
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Orange, California, United States
Baton Rouge General
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Baton Rouge, Louisiana, United States
University of Iowa
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Iowa City, Iowa, United States
University of Florida (Health Shands Burn Center)
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Gainesville, Florida, United States
University of Missouri
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Columbia, Missouri, United States
University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, United States
University of Wisconsin Hospital
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Madison, Wisconsin, United States
Wake Forest University
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Winston-Salem, North Carolina, United States