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

NCT03005054 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: STRATA2014W81XWH-16-C-0202
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 4

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.

Conditions

Trauma-related Wound; Burns; Skin Wound

Keywords

Full-thickness; Acute trauma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• 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 of Donor Sites at 3, 6, and 12 Months

  within 3, 6, and 12 Months

Study Arms (1)

StrataGraft skin tissue

EXPERIMENTAL

Biological: StrataGraft Skin Tissue; Procedure: Autograft

Interventions

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®).

StrataGraft skin tissue

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.

StrataGraft skin tissue

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18-65 years, inclusive
• Written informed consent
• Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
• 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
• Full-thickness complex skin defects requiring excision and autografting
• Study treatment sites on the torso and limbs may be up to 200 cm2 in cohort 1 and 400 cm2 in cohort 2
• For thermal burns only, first excision and grafting of treatment sites

You may not qualify if:

• Pregnant women and prisoners
• Subjects receiving systemic immunosuppressive therapy
• Subjects with a known history of malignancy
• Preadmission insulin-dependent diabetic subjects
• Subjects with concurrent conditions that in the opinion of the investigator may compromise subject safety or study objectives
• Expected survival of less than three months
• Participation in the treatment group of an interventional study within the 90 days prior to enrollment
• Chronic wounds
• The face, head, neck, hands, feet, buttocks, perineum, and area over joints
• Treatment sites with exposed tendon or bony prominences
• Chemical and electrical burns
• Treatment sites adjacent to unexcised eschar
• Clinical suspicion of infection at the anticipated treatment sites

Sponsors & Collaborators

• Stratatech, a Mallinckrodt Company: lead

Study Sites (4)

Arizona Burn Center

Phoenix, Arizona, 85008, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

U.S. Army Institute of Surgical Research Adult Burn Center

Fort Sam Houston, Texas, 78234-6315, United States

Location

University of Wisconsin Hospital

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Transplantation, Autologous

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

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.

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Mallinckrodt

clinicaltrials@mnk.com

800-844-2830

Study Officials

• Study Director

  Mallinckrodt

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: See detailed description

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 29, 2016
• Study Start: April 24, 2017
• Primary Completion: March 26, 2019
• Study Completion: March 26, 2019
• Last Updated: August 3, 2021
• Results First Posted: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)