StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements

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

Tracking Information

• First Submitted Date: December 21, 2016
• First Posted Date: December 29, 2016
• Results First Submitted Date: June 18, 2021
• Results First Posted Date: July 12, 2021
• Last Update Posted Date: July 14, 2021
• Actual Study Start Date: May 30, 2017
• Actual Primary Completion Date: July 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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: Interventional
• Study Phase: Phase 3

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

See detailed description

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Burn, Thermal

Intervention

• 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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 16, 2019): 71
• Original Estimated Enrollment (submitted: December 22, 2016): 70
• Actual Study Completion Date: March 27, 2020
• Actual Primary Completion Date: July 31, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03005106
• Other Study ID Numbers: 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

• 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: Stratatech, a Mallinckrodt Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Team Leader; Stratatech, a Mallinckrodt Company

• PRS Account: Mallinckrodt
• Verification Date: July 2021