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

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ClinicalTrials.gov Identifier: NCT03005054
Recruitment Status : Terminated (Protracted enrollment and limited wound closure in the first three subjects)
First Posted : December 29, 2016
Results First Posted : August 3, 2021
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt ( Stratatech, a Mallinckrodt Company )

Brief Summary:

About 20 participants will be enrolled in this trial if they have had an accident that damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their body.

This condition is called full-thickness complex skin defects resulting from acute traumatic skin loss.

Participants will be treated with StrataGraft skin tissue to evaluate it's safety and effectiveness for use in treating full-thickness complex skin defects.


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

Detailed Description:
The objective of this range-finding study was to assess the safety, tolerability, and efficacy of single or repeated application of StrataGraft skin tissue in full-thickness complex skin defects resulting from acute traumatic skin loss (eg, thermal burns or degloving injuries) requiring surgical excision and autografting.

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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 : March 26, 2019

Resource links provided by the National Library of Medicine


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. Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months [ Time Frame: 3 months ]
    Complete wound closure is defined as ≥95% re-epithelialization of all treatment sites with the absence of drainage


Secondary Outcome Measures :
  1. Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months [ Time Frame: within 3 months ]
  2. Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months [ Time Frame: within 3, 6 and 12 months ]
  3. Percent Wound Closure at 3, 6, and 12 Months [ Time Frame: within 3, 6, and 12 Months ]
  4. Cosmesis of Treatment Sites at 3, 6, and 12 Months [ Time Frame: within 3, 6, and 12 Months ]
    Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance

  5. Cosmesis of Donor Sites at 3, 6, and 12 Months [ Time Frame: within 3, 6, and 12 Months ]
    Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance

  6. Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28 [ Time Frame: at days 3, 7, 14, 21, and 28 ]


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
Criteria

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% Total Body Surface Area (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 ClinicalTrials.gov identifier (NCT number): NCT03005054


Locations
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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
Investigators
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Study Director: Study Director Mallinckrodt
  Study Documents (Full-Text)

Documents provided by Mallinckrodt ( Stratatech, a Mallinckrodt Company ):
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Responsible Party: Stratatech, a Mallinckrodt Company
ClinicalTrials.gov Identifier: NCT03005054    
Other Study ID Numbers: STRATA2014
W81XWH-16-C-0202 ( Other Grant/Funding Number: DoD )
First Posted: December 29, 2016    Key Record Dates
Results First Posted: August 3, 2021
Last Update Posted: August 3, 2021
Last Verified: July 2021
Individual Participant Data (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 (NCT03005054) 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mallinckrodt ( Stratatech, a Mallinckrodt Company ):
Full-thickness
Acute trauma
Additional relevant MeSH terms:
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Wounds and Injuries