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

Completed · Phase 3

Conditions studied: Deep Partial-thickness Burn

In brief

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.

Key facts

Study ID

NCT04123548

Run by

Stratatech, a Mallinckrodt Company

People needed

52

Starts

2020-02-18

Expected to finish

2022-01-26

Last updated by the study team

2023-11-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.