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StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

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: NCT03005054
Recruitment Status : Terminated (Protracted enrollment and limited efficacy in the first three subjects)
First Posted : December 29, 2016
Last Update Posted : March 23, 2020
Information provided by (Responsible Party):
Mallinckrodt ( Stratatech, a Mallinckrodt Company )

Brief Summary:
The proposed study is designed as a phase II open-label, controlled, randomized, multicenter, dose-escalation study of the safety, tolerability, and efficacy of a single or multiple applications of StrataGraft skin tissue as an alternative to autografting in promoting the healing of excised full-thickness complex skin defects resulting from acute traumatic skin loss. The proposed study population will include patients with up to 49% Total Body Surface Area (TBSA) complex skin defects including a full-thickness component. The study has been designed to focus on the evaluation of safety and tolerability of prolonged exposure to increasing amounts of a single or multiple applications of StrataGraft skin tissue, while also assessing the potential for StrataGraft tissue to promote healing of the full-thickness component of these complex skin defects as an alternative to donor site harvesting and autografting. Targeted enrollment for this study is up to 20 subjects with complex skin defects due to acute traumatic skin loss which require surgical excision and autografting. Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving StrataGraft skin tissue.

Condition or disease Intervention/treatment Phase
Trauma-related Wound Burns Skin Wound Biological: StrataGraft Skin Tissue Procedure: Autograft Phase 2

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 : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: See detailed description
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Single or Multiple Applications of StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects
Actual Study Start Date : April 24, 2017
Actual Primary Completion Date : March 26, 2019
Actual Study Completion Date : October 31, 2019

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 complex skin defects. 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 wound.

Primary Outcome Measures :
  1. Percent area of the StrataGraft treatment site requiring autografting by three months [ Time Frame: 3 months ]
    The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined.

  2. Wound closure of the treatment sites at three months [ Time Frame: 3 months ]
    Determination of complete wound closure of both treatment sites will be evaluated at three months.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Men and women aged 18-65 years, inclusive
  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. Complex skin defects of up to 49% TBSA requiring excision and autografting

    • Total skin defect may consist of more than one wound area
  5. Full-thickness complex skin defects requiring excision and autografting
  6. Study treatment sites on the torso and limbs may be up to 200 cm2 in cohort 1 and 400 cm2 in cohort 2
  7. For thermal burns only, first excision and grafting of treatment sites

Exclusion Criteria:

  1. Pregnant women and prisoners
  2. Subjects receiving systemic immunosuppressive therapy
  3. Subjects with a known history of malignancy
  4. Preadmission insulin-dependent diabetic subjects
  5. Subjects with concurrent conditions that in the opinion of the investigator may compromise subject safety or study objectives
  6. Expected survival of less than three months
  7. Participation in the treatment group of an interventional study within the 90 days prior to enrollment
  8. Chronic wounds
  9. The face, head, neck, hands, feet, buttocks, perineum, and area over joints
  10. Treatment sites with exposed tendon or bony prominences
  11. Chemical and electrical burns
  12. Treatment sites adjacent to unexcised eschar
  13. Clinical suspicion 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): NCT03005054

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United States, Arizona
Arizona Burn Center
Phoenix, Arizona, United States, 85008
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
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
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Responsible Party: Stratatech, a Mallinckrodt Company Identifier: NCT03005054    
Other Study ID Numbers: STRATA2014
W81XWH-16-C-0202 ( Other Grant/Funding Number: DoD )
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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