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

NCT ID: NCT04123548

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-18
• Study Completion Date: 2022-01-26

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.

Conditions

Deep Partial-thickness Burn

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

StrataGraft

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.

Group Type: EXPERIMENTAL

StrataGraft skin tissue

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Experimental skin tissue

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stratatech, a Mallinckrodt Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Leader

Role: STUDY_DIRECTOR

Stratatech, a Mallinckrodt Company

Locations

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

Countries

United States

References

Holmes Iv JH, Gibson ALF, Short T, Joe VC, Litt J, Carson J, Carter JE, Wibbenmeyer L, Hahn H, Smiell JM, Rutan R, Wu R, Shupp JW. A phase 3b, open-label, single-arm, multicenter, expanded-access study of the safety and clinical outcomes of StrataGraft(R) treatment in adults with deep partial-thickness thermal burns. Burns. 2024 Nov;50(8):2013-2022. doi: 10.1016/j.burns.2024.05.023. Epub 2024 Jun 6.

Reference Type: DERIVED

PMID: 39043513 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MNK01053115

Identifier Type: -

Identifier Source: org_study_id