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
• Last Update Posted: May 1, 2020
• 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
• Last Update Posted Date: May 1, 2020
• 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: 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 ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• 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: The proposed registration study is designed as 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. The proposed study will include patients with 3-49% total body surface area (TBSA) complex skin defects due to thermal burns with intact dermal elements for which excision and autografting are clinically indicated. The study has been designed to focus on the evaluation of efficacy and safety of StrataGraft skin tissue, while also assessing the potential for StrataGraft skin tissue to promote healing of complex skin defects due to thermal burns as an alternative to donor site harvesting and autografting. Targeted enrollment for this study is approximately 70 subjects with complex skin defects caused by thermal burns that containing intact dermal elements and for which surgical excision and autografts are clinically indicated.
• Detailed Description: After surgical excision of nonviable tissue, two comparable areas of comparable depth on each subject will be identified and the areas will be randomized to receive StrataGraft skin tissue or a surgically harvested autograft as the intrapatient comparator.
• 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

• Trauma-related Wound
• Burns
• Skin Wound

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 *: Not Provided

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: Not Provided
• Responsible Party: Mallinckrodt ( Stratatech, a Mallinckrodt Company )
• Study Sponsor: Stratatech, a Mallinckrodt Company
• Collaborators: Not Provided

Investigators

• Study Director: Study Director; Mallinckrodt

• PRS Account: Mallinckrodt
• Verification Date: April 2020