StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements
|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: NCT03005106|
Recruitment Status : Completed
First Posted : December 29, 2016
Results First Posted : July 12, 2021
Last Update Posted : July 14, 2021
About 70 participants will be enrolled. They will have complex skin defects because of burns caused by heat.
The burns will:
- be on 3-49% of the participant's total body surface area (TBSA)
- require surgery for skin replacement
- include intact dermal elements
The burns are called deep, partial-thickness thermal burns because the skin was damaged by heat but still has some dermis that was not damaged.
The dermis is the layer of skin under the outer layer (epidermis). It is the thickest layer of the skin that provides strength and flexibility to the skin.
All patients will receive both treatments, but on different areas of their burns. Their wounds will not be compared to other patients. One treatment area on their own body will be compared to the other one.
This will help to find out if StrataGraft is safe and effective for deep partial thickness burns. It will also see if StrataGraft might help healing enough to use it instead of the patient's own healthy skin to repair the damage.
|Condition or disease||Intervention/treatment||Phase|
|Burn, Thermal||Biological: StrataGraft Skin Tissue Procedure: Autograft||Phase 3|
Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||See detailed description|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Open-label, Controlled, Randomized, Multicenter Study Evaluating the Efficacy and Safety of StrataGraft Skin Tissue in Promoting Autologous Skin Tissue Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements and for Which Excision and Autografts Are Clinically Indicated|
|Actual Study Start Date :||May 30, 2017|
|Actual Primary Completion Date :||July 31, 2019|
|Actual Study Completion Date :||March 27, 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 burns. 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 burn wound.
- Percent Area of Treatment Sites Requiring Autografting by Month 3 [ Time Frame: 3 Months ]Percent area autografted by Month 3 is the sum of the percent areas at each study session/visit, up to and including Study Session 7/Month 3 (± 14 d).
- Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3) [ Time Frame: Month 3 ]Wound closure of the treatment site was defined as complete skin re-epithelialization and the absence of drainage. A participant whose StrataGraft treatment site achieves durable wound closure without autograft placement is classified as a responder.
- Pain at the Designated Donor Sites by Day 14 [ Time Frame: Day 3, Day 7 and Day 14, average of the 3 days reported ]Pain scores from the FACES scale range from 0 (no pain) to 5 (worst pain). Pain scores from Day 3, Day 7, and Day 14 (where available) are averaged for the summary statistics.
- Total Scar Assessment (POSAS) Score by Observer at Month 3 [ Time Frame: at Month 3 ]Total Score is the sum of the scores for vascularization, pigmentation, thickness, relief, pliability, and surface area. For each of the 6 assessment categories, the scale ranged from 1=normal skin to 10=worst scar imaginable, with the highest possible score of 10. A higher score indicates worse scarring, so the best possible total score for the 6 categories is 6, and the worst possible score is 60.
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): NCT03005106
|United States, Alabama|
|University of South Alabama Medical Center|
|Mobile, Alabama, United States, 36617|
|United States, Arizona|
|Arizona Burn Center at Maricopa Medical Center|
|Phoenix, Arizona, United States, 85008|
|United States, California|
|Universtiy of California - Irvine Health Regional Burn Center|
|Orange, California, United States, 92868|
|Sacramento, California, United States, 95817|
|United States, District of Columbia|
|MedStar Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|United States, Florida|
|University of Florida Health Shands Burn Center|
|Gainesville, Florida, United States, 32610|
|Tampa General Hospital - Regional Burn Center|
|Tampa, Florida, United States, 33606|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, Louisiana|
|Baton Rouge Medical Center|
|Baton Rouge, Louisiana, United States, 70809|
|University Medical Center|
|New Orleans, Louisiana, United States, 70112|
|United States, Missouri|
|University of Missouri|
|Columbia, Missouri, United States, 65212|
|United States, North Carolina|
|Wake Forest University Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15219|
|United States, Tennessee|
|Regional Medical Center Firefighters Burn Center|
|Memphis, Tennessee, United States, 38103|
|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:||Clinical Team Leader||Stratatech, a Mallinckrodt Company|