Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt ( Stratatech, a Mallinckrodt Company )

Brief Summary:

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 is available outside the clinical trial.   More info ...

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: See detailed description
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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®).

Procedure: Autograft
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.




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Subject-specific criteria:

  1. Men and women aged ≥ 18 years
  2. Written informed consent
  3. Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
  4. Clinical expectation that the study donor site will heal without grafting
  5. Complex skin defects of 3-49% TBSA

    • Total burn may consist of more than one area

    Treatment site-specific criteria:

  6. Thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated
  7. Total of both study treatment areas can be up to 2000 cm2
  8. First excision and grafting of study treatment sites
  9. Thermal burn(s) on the torso, arms, or legs

Exclusion Criteria

Subject-specific criteria:

  1. Pregnant women
  2. Prisoners
  3. Subjects receiving systemic immunosuppressive therapy
  4. Subjects with a known history of malignancy
  5. Preadmission insulin-dependent diabetic subjects
  6. Subjects with concurrent conditions that in the opinion of the investigator may compromise subject safety or study objectives
  7. Expected survival of less than three months
  8. Participation in the treatment group of an interventional study within 90 days prior to enrollment

    Treatment site-specific criteria:

  9. Full-thickness burns
  10. Chronic wounds
  11. The face, head, neck, hands, feet, buttocks, and area over joints
  12. Treatment sites immediately adjacent to unexcised eschar
  13. Clinical or laboratory determination of infection at the anticipated treatment sites

Information from the National Library of Medicine

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


Locations
Layout table for location information
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
UC Davis
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
Sponsors and Collaborators
Stratatech, a Mallinckrodt Company
Investigators
Layout table for investigator information
Study Director: Clinical Team Leader Stratatech, a Mallinckrodt Company
  Study Documents (Full-Text)

Documents provided by Mallinckrodt ( Stratatech, a Mallinckrodt Company ):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Stratatech, a Mallinckrodt Company
ClinicalTrials.gov Identifier: NCT03005106    
Other Study ID Numbers: STRATA2016
First Posted: December 29, 2016    Key Record Dates
Results First Posted: July 12, 2021
Last Update Posted: July 14, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03005106) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mallinckrodt ( Stratatech, a Mallinckrodt Company ):
Trauma-related wound
Deep partial thickness
Skin wound
Additional relevant MeSH terms:
Layout table for MeSH terms
Burns
Wounds and Injuries