Clinical trial NCT04123548: StrataGraft® Skin Tissue Expanded Access at Specific Study Sites ( StrataCAT )
Official title: A Multicenter, Open-label, Study of StrataGraft® Skin Tissue in Adult Subjects With Deep Partial-Thickness Thermal Burns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Deep Partial-thickness Burn
Keywords: Alternative to Autograft
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2019-10-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Washington
country: United States
facility: MedStar Health Research Institute
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida (Health Shands Burn Center)
state: Florida
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baton Rouge
country: United States
facility: Baton Rouge General
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Madison
country: United States
facility: University of Wisconsin Hospital
state: Wisconsin
Study officials:
affiliation: Stratatech, a Mallinckrodt Company
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: