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

Phase 2

Terminated

• Conditions: Skin Wound; Trauma-related Wound; Burns
• Interventions: Biological: StrataGraft Skin Tissue; Procedure: Autograft

• Registration Number: NCT03005054
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2016-12-22
• Study First Posted: 2016-12-29
• Study Start: 2017-04-24
• Primary Completion: 2019-03-26
• Study Completion: 2019-03-26
• Disposition First Submitted: 2020-03-17
• Results First Submitted: 2021-03-10
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-13
• Disposition First Submitted QC: 2021-07-13
• Last Update Submitted: 2021-07-13
• Results First Posted: 2021-08-03
• Disposition First Posted: 2021-08-03
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
StrataGraft skin tissue	Autograft	-
StrataGraft skin tissue	StrataGraft Skin Tissue	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (4)

Arizona Burn Center; 🇺🇸 Phoenix, Arizona, United States

Wake Forest University Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, 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