Completed

NCT Number: NCT04123548

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

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.

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Key information

Conditions

Deep Partial-thickness Burn

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of California Irvine, Orange, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

StrataGraft Skin Tissue

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.

Other names: Experimental skin tissue

Primary outcomes

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame: 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).

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).

Sponsors and collaborators

Lead sponsor

Stratatech, a Mallinckrodt Company

Industry

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Oct 11, 2019
Registry last updated: Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.