NCT04123548

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Stratatech, a Mallinckrodt Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Deep Partial-thickness Burn

Interventions

Type	Name	Description
BIOLOGICAL	StrataGraft skin tissue	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.

Timeline

• Start date: 2020-02-18
• Primary completion: 2022-01-26
• Completion: 2022-01-26
• First posted: 2019-10-11
• Last updated: 2023-11-09
• Results posted: 2023-11-09

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study