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

Deep Partial-thickness Burn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04123548
• Other study ID #: MNK01053115
• Status: Completed
• Phase: Phase 3
• Start date: February 18, 2020
• Est. completion date: January 26, 2022

Study information

• Verified date: October 2023
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 26, 2022
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Partial-thickness Burn

Intervention

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.

Locations

Country	Name	City	State
United States	Baton Rouge General	Baton Rouge	Louisiana
United States	University of Missouri	Columbia	Missouri
United States	University of Florida (Health Shands Burn Center)	Gainesville	Florida
United States	University of Iowa	Iowa City	Iowa
United States	University of Wisconsin Hospital	Madison	Wisconsin
United States	University Medical Center New Orleans	New Orleans	Louisiana
United States	University of California Irvine	Orange	California
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	MedStar Health Research Institute	Washington	District of Columbia
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Stratatech, a Mallinckrodt Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).