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. 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: NCT03005054|
Recruitment Status : Recruiting
First Posted : December 29, 2016
Last Update Posted : November 14, 2018
|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)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
|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.
- Wound closure of the treatment sites at three months [ Time Frame: 3 months ]Determination of complete wound closure of both treatment sites will be evaluated at three months.
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
|Contact: Kristen Schaeve||800-556-3314||ClinicalTrials@mnk.com|
|United States, North Carolina|
|Wake Forest University Baptist Medical Center||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Texas|
|U.S. Army Institute of Surgical Research Adult Burn Center||Recruiting|
|Fort Sam Houston, Texas, United States, 78234-6315|
|United States, Wisconsin|
|University of Wisconsin Hospital||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Study Director:||Study Director||Mallinckrodt|