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
|First Submitted Date||October 6, 2019|
|First Posted Date||October 11, 2019|
|Last Update Posted Date||October 6, 2021|
|Brief Title||StrataGraft Skin Tissue Expanded Access at Specific Study Sites|
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.
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.
|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.|
|Study Type||Expanded Access|
|Expanded Access Type||Treatment IND/Protocol|
|Intervention||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
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Expanded Access Status||Approved for marketing|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Responsible Party||Mallinckrodt ( Stratatech, a Mallinckrodt Company )|
|Study Sponsor||Stratatech, a Mallinckrodt Company|
|Verification Date||September 2021|