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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04123548
Expanded Access Status : Approved for marketing
First Posted : October 11, 2019
Last Update Posted : October 6, 2021
Information provided by (Responsible Party):
Mallinckrodt ( Stratatech, a Mallinckrodt Company )

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 is an investigational tissue that can be used as an alternative to an autograft.

  • StrataGraft skin tissue is in late stage clinical development for deep partial-thickness burns.
  • There have been no safety concerns reported to date

The sponsor submitted a treatment protocol to FDA for experienced doctors to keep using StrataGraft before it is marketed (expanded access), so the product is available (by invitation only at the locations listed).

The main purpose of the study is to allow patients to receive StrataGraft prior to approval by the Food and Drug Administration for the treatment of deep partial-thickness burns. The primary outcome measure will be the number of participants with adverse events and safety concerns.

Condition or disease Intervention/treatment
Deep Partial-thickness Burn Biological: StrataGraft skin tissue

Detailed Description:
The primary purpose of this trial is to provide expanded access to StrataGraft for thermally induced deep partial-thickness burns that contain intact dermal elements and for which surgical excision and autograft would normally be part of the clinical management.

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: A Multicenter, Open-label, Study of StrataGraft® Skin Tissue in Adult Subjects With Deep Partial-Thickness Thermal Burns

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Intervention Details:
  • Biological: StrataGraft skin tissue
    StrataGraft skin tissue is delivered as a single topical application to no more than 3 separate burn sites, totaling up to approximately 1000 cm^2 of treatment area using no more than 10 tissues.
    Other Name: Experimental skin tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

To be considered for inclusion, a patient 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 patient 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123548

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United States, Arizona
Arizona Burn Center
Phoenix, Arizona, United States, 85008
United States, California
University of California Irvine
Orange, California, United States, 92868-3298
United States, District of Columbia
MedStar Health Research Institute
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida (Health Shands Burn Center)
Gainesville, Florida, United States, 32610
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Louisiana
Baton Rouge General
Baton Rouge, Louisiana, United States, 70809
University Medical Center New Orleans
New Orleans, Louisiana, United States, 70113
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 33136
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
University of Pittsurgh Medical Center
Pittsburgh, Pennsylvania, United States, 15219
United States, Wisconsin
University of Wisconsin Hospital
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Stratatech, a Mallinckrodt Company
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Study Director: Global Clinical Leader Stratatech, a Mallinckrodt Company
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Responsible Party: Stratatech, a Mallinckrodt Company
ClinicalTrials.gov Identifier: NCT04123548    
Other Study ID Numbers: MNK01053115
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: September 2021
Keywords provided by Mallinckrodt ( Stratatech, a Mallinckrodt Company ):
Alternative to Autograft