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Trial record 3 of 5 for:    stratagraft

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
Last Update Posted : May 1, 2020
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
Last Update Posted Date May 1, 2020
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: 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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
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 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  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
  • Trauma-related Wound
  • Burns
  • Skin Wound
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 * Not Provided

*   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 Not Provided
Responsible Party Mallinckrodt ( Stratatech, a Mallinckrodt Company )
Study Sponsor  ICMJE Stratatech, a Mallinckrodt Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director Mallinckrodt
PRS Account Mallinckrodt
Verification Date April 2020

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