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

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

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.

Study Overview

• Status: Completed
• Conditions: Deep Partial-thickness Burn
• Intervention / Treatment: Biological: StrataGraft skin tissue

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868-3298
      • University of California Irvine
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Health Research Institute
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida (Health Shands Burn Center)
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Baton Rouge General
    • New Orleans, Louisiana, United States, 70113
      • University Medical Center New Orleans
  • Missouri
    • Columbia, Missouri, United States, 33136
      • University of Missouri
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • University of Pittsburgh Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Experimental skin tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).

Collaborators and Investigators

• Sponsor: Stratatech, a Mallinckrodt Company
• Investigators: Study Director: Global Clinical Leader, Stratatech, a Mallinckrodt Company

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2020
• Primary Completion (Actual): January 26, 2022
• Study Completion (Actual): January 26, 2022

Study Registration Dates

• First Submitted: October 6, 2019
• First Submitted That Met QC Criteria: October 6, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Alternative to Autograft
• Other Study ID Numbers: MNK01053115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No