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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 )

Tracking Information
First Submitted Date  ICMJE December 21, 2016
First Posted Date  ICMJE December 29, 2016
Results First Submitted Date  ICMJE June 18, 2021
Results First Posted Date  ICMJE July 12, 2021
Last Update Posted Date July 14, 2021
Actual Study Start Date  ICMJE May 30, 2017
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2021)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2016)
  • The difference in the percent area of the StrataGraft treatment site and control autograft treatment site that is autografted by 3 months [ Time Frame: 3 Months ]
  • The proportion of subjects achieving durable wound closure of the StrataGraft treatment site at 3 months without autograft placement [ Time Frame: 3 Months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2021)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
See detailed description
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Burn, Thermal
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: StrataGraft Skin Tissue
Interventions:
  • Biological: StrataGraft Skin Tissue
  • Procedure: Autograft
Publications * Gibson ALF, Holmes JH 4th, Shupp JW, Smith D, Joe V, Carson J, Litt J, Kahn S, Short T, Cancio L, Rizzo J, Carter JE, Foster K, Lokuta MA, Comer AR, Smiell JM, Allen-Hoffmann BL. A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft® construct in patients with deep partial-thickness thermal burns. Burns. 2021 Aug;47(5):1024-1037. doi: 10.1016/j.burns.2021.04.021. Epub 2021 Apr 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2019)
71
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2016)
70
Actual Study Completion Date  ICMJE March 27, 2020
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03005106
Other Study ID Numbers  ICMJE STRATA2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Current Responsible Party Mallinckrodt ( Stratatech, a Mallinckrodt Company )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Stratatech, a Mallinckrodt Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Team Leader Stratatech, a Mallinckrodt Company
PRS Account Mallinckrodt
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP