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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04123548|
Expanded Access Status : Available
First Posted : October 11, 2019
Last Update Posted : May 4, 2020
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.
|Condition or disease||Intervention/treatment|
|Deep Partial-thickness Burn||Biological: StrataGraft skin tissue|
|Study Type :||Expanded Access|
|Expanded Access Type :||Treatment IND/Protocol|
|Official Title:||A Multicenter, Open-label, Study of StrataGraft® Skin Tissue in Adult Subjects With Deep Partial-Thickness Thermal Burns|
- 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
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
|Contact: Medical Information Call Center||800-556-3314 ext email@example.com|
|United States, Arizona|
|Arizona Burn Center||Available|
|Phoenix, Arizona, United States, 85008|
|United States, California|
|University of California Irvine||Available|
|Orange, California, United States, 92868-3298|
|United States, District of Columbia|
|MedStar Health Research Institute||Available|
|Washington, District of Columbia, United States, 20010|
|United States, Louisiana|
|Baton Rouge General||Available|
|Baton Rouge, Louisiana, United States, 70809|
|United States, Missouri|
|University of Missouri||Available|
|Columbia, Missouri, United States, 33136|
|United States, North Carolina|
|Wake Forest University||Available|
|Winston-Salem, North Carolina, United States, 27157|
|Study Director:||Global Clinical Leader||Stratatech, a Mallinckrodt Company|