StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects
|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: NCT03005054|
Recruitment Status : Terminated (Protracted enrollment and limited wound closure in the first three subjects)
First Posted : December 29, 2016
Results First Posted : August 3, 2021
Last Update Posted : August 3, 2021
About 20 participants will be enrolled in this trial if they have had an accident that damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their body.
This condition is called full-thickness complex skin defects resulting from acute traumatic skin loss.
Participants will be treated with StrataGraft skin tissue to evaluate it's safety and effectiveness for use in treating full-thickness complex skin defects.
|Condition or disease||Intervention/treatment||Phase|
|Trauma-related Wound Burns Skin Wound||Biological: StrataGraft Skin Tissue Procedure: Autograft||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||See detailed description|
|Masking:||None (Open Label)|
|Official Title:||Open-label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Single or Multiple Applications of StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects|
|Actual Study Start Date :||April 24, 2017|
|Actual Primary Completion Date :||March 26, 2019|
|Actual Study Completion Date :||March 26, 2019|
|Experimental: StrataGraft skin tissue||
Biological: StrataGraft Skin Tissue
StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).
The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
- Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months [ Time Frame: 3 months ]The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined.
- Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months [ Time Frame: 3 months ]Complete wound closure is defined as ≥95% re-epithelialization of all treatment sites with the absence of drainage
- Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months [ Time Frame: within 3 months ]
- Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months [ Time Frame: within 3, 6 and 12 months ]
- Percent Wound Closure at 3, 6, and 12 Months [ Time Frame: within 3, 6, and 12 Months ]
- Cosmesis of Treatment Sites at 3, 6, and 12 Months [ Time Frame: within 3, 6, and 12 Months ]Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance
- Cosmesis of Donor Sites at 3, 6, and 12 Months [ Time Frame: within 3, 6, and 12 Months ]Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance
- Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28 [ Time Frame: at days 3, 7, 14, 21, and 28 ]
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): NCT03005054
|United States, Arizona|
|Arizona Burn Center|
|Phoenix, Arizona, United States, 85008|
|United States, North Carolina|
|Wake Forest University Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Texas|
|U.S. Army Institute of Surgical Research Adult Burn Center|
|Fort Sam Houston, Texas, United States, 78234-6315|
|United States, Wisconsin|
|University of Wisconsin Hospital|
|Madison, Wisconsin, United States, 53792|
|Study Director:||Study Director||Mallinckrodt|