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

Burns Clinical Trial

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

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
• 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
• 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

Related Conditions & MeSH terms

• Burns
• Skin Wound
• Trauma-related Wound
• Wounds and Injuries

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