Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started

Description

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). 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.

Official Title

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

Details

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.

Keywords

Deep Partial-thickness Burn Alternative to Autograft StrataGraft skin tissue

Eligibility

You can join if…

Open to people ages 18 years and up

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:
  • 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.

You CAN'T join if...

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

Locations

  • University of California Irvine not accepting new patients
    Orange California 92868-3298 United States
  • Arizona Burn Center not accepting new patients
    Phoenix Arizona 85008 United States

Details

Status
not accepting new patients
Start Date
Sponsor
Stratatech, a Mallinckrodt Company
ID
NCT04123548
Study Type
Expanded Access
Last Updated