Phase 3 N=52 Treatment

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

Deep Partial-thickness Burn

Bottom Line

View on ClinicalTrials.gov: NCT04123548 ↗

Enrolled (actual)

Serious AEs

19.2%

Results posted

Nov 2023

Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 46 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: StrataGraft skin tissue (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stratatech, a Mallinckrodt Company
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs)	46	—

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.

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:
that are the right size for treatment areas,
with intact dermal elements for which excision and autografting are clinically indicated, and
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04123548). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.