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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. Identifier: NCT03005106
Recruitment Status : Completed
First Posted : December 29, 2016
Last Update Posted : May 1, 2020
Information provided by (Responsible Party):
Mallinckrodt ( Stratatech, a Mallinckrodt Company )

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.

Condition or disease Intervention/treatment Phase
Trauma-related Wound Burns Skin Wound Biological: StrataGraft Skin Tissue Procedure: Autograft Phase 3

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.

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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

MedlinePlus related topics: Burns

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. 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 ]
  2. The proportion of subjects achieving durable wound closure of the StrataGraft treatment site at 3 months without autograft placement [ Time Frame: 3 Months ]

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT03005106

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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
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Study Director: Study Director Mallinckrodt
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Stratatech, a Mallinckrodt Company Identifier: NCT03005106    
Other Study ID Numbers: STRATA2016
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries