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

Stratatech, a Mallinckrodt Company52 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Deep Partial-thickness Burn

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

University of California Irvine

Orange, California, United States

MedStar Health Research Institute

Washington D.C., District of Columbia, United States

University of Florida (Health Shands Burn Center)

Gainesville, Florida, United States

University of Iowa

Iowa City, Iowa, United States

Baton Rouge General

Baton Rouge, Louisiana, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

University of Missouri

Columbia, Missouri, United States

Wake Forest University

Winston-Salem, North Carolina, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

University of Wisconsin Hospital

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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).

Time frame: 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).