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

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.

• StrataGraft Skin Tissue (Biological): 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®).
• Autograft (Procedure): 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 outcomes

• Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months [3 months]: The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined.
• Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months [3 months]: Complete wound closure is defined as ≥95% re-epithelialization of all treatment sites with the absence of drainage

Secondary outcomes

• Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months [within 3 months]
• Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months [within 3, 6 and 12 months]
• Percent Wound Closure at 3, 6, and 12 Months [within 3, 6, and 12 Months]
• Cosmesis of Treatment Sites at 3, 6, and 12 Months [within 3, 6, and 12 Months]: Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance
• Cosmesis of Donor Sites at 3, 6, and 12 Months [within 3, 6, and 12 Months]: Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance
• Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28 [at days 3, 7, 14, 21, and 28]

Sex: All, ages: 18 Years to 65 Years

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

Participant flow

Outcome results

• Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months (Primary), Number, percentage of treatment site: StrataGraft Skin Tissue 100
• Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months (Primary), Number, percentage of participants: StrataGraft Skin Tissue 100
• Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months (Secondary)
• Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months (Secondary)
• Percent Wound Closure at 3, 6, and 12 Months (Secondary)
• Cosmesis of Treatment Sites at 3, 6, and 12 Months (Secondary)
• Cosmesis of Donor Sites at 3, 6, and 12 Months (Secondary)
• Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28 (Secondary)

Adverse events

Time frame: 3 months

Serious adverse events by term

Other adverse events by term

Limitations and caveats: Due to protracted enrollment and limited wound closure in the first three subjects, the Sponsor decided to end further enrollment and the study was terminated with only 3 subjects enrolled into Cohort 1. No participants were enrolled into Cohort 2. Therefore, posted results include primary outcome measures for the 3 subjects enrolled, but no data for the secondary outcome measures.

• Study Protocol and Statistical Analysis Plan (PDF, 2017-03-23)

• Study Director, Study director, Mallinckrodt