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

Stratatech

Status and phase: Completed; Phase 3

Conditions: Deep Partial-thickness Burn

Treatments: Biological: StrataGraft skin tissue

Study type: Interventional

Funder types: Industry

Identifiers

NCT04123548

MNK01053115

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

StrataGraft

Experimental group

Description:

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.

Treatment:

Biological: StrataGraft skin tissue