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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03005054
Other study ID # STRATA2014
Secondary ID W81XWH-16-C-0202
Status Terminated
Phase Phase 2
First received
Last updated
Start date April 24, 2017
Est. completion date March 26, 2019

Study information

Verified date July 2021
Source Mallinckrodt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date March 26, 2019
Est. primary completion date March 26, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


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 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.

Locations

Country Name City State
United States U.S. Army Institute of Surgical Research Adult Burn Center Fort Sam Houston Texas
United States University of Wisconsin Hospital Madison Wisconsin
United States Arizona Burn Center Phoenix Arizona
United States Wake Forest University Baptist Medical Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Stratatech, a Mallinckrodt Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined. 3 months
Primary Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months Complete wound closure is defined as =95% re-epithelialization of all treatment sites with the absence of drainage 3 months
Secondary Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months within 3 months
Secondary Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months within 3, 6 and 12 months
Secondary Percent Wound Closure at 3, 6, and 12 Months within 3, 6, and 12 Months
Secondary Cosmesis of Treatment Sites at 3, 6, and 12 Months Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance within 3, 6, and 12 Months
Secondary Cosmesis of Donor Sites at 3, 6, and 12 Months Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance within 3, 6, and 12 Months
Secondary Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28 at days 3, 7, 14, 21, and 28
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