Clinical trial NCT03005054: StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Trauma-related Wound
Burns
Skin Wound
Keywords: Full-thickness
Acute trauma
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2016-12-29
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: See detailed description
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months
timeFrame: 3 months
measure: Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months
timeFrame: 3 months
Secondary outcomes:
measure: Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months
timeFrame: within 3 months
measure: Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months
timeFrame: within 3, 6 and 12 months
measure: Percent Wound Closure at 3, 6, and 12 Months
timeFrame: within 3, 6, and 12 Months
measure: Cosmesis of Treatment Sites at 3, 6, and 12 Months
timeFrame: within 3, 6, and 12 Months
measure: Cosmesis of Donor Sites at 3, 6, and 12 Months
timeFrame: within 3, 6, and 12 Months
measure: Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28
timeFrame: at days 3, 7, 14, 21, and 28
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Burn Center
state: Arizona
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Fort Sam Houston
country: United States
facility: U.S. Army Institute of Surgical Research Adult Burn Center
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Hospital
state: Wisconsin
Study officials:
affiliation: Mallinckrodt
name: Study Director
role: STUDY_DIRECTOR
References: