Trauma-related Wound, Burns, Skin Wound
Conditions
Keywords
Full-thickness, Acute trauma
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.
Interventions
BIOLOGICALStrataGraft 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®).
PROCEDUREAutograft
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.
Sponsors
Stratatech, a Mallinckrodt Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
See detailed description
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | — |
| 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 |
| Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months | within 3, 6 and 12 months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| StrataGraft Skin Tissue 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®).
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. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | StrataGraft Skin Tissue |
|---|---|
| Age, Continuous | 53 years |
| Race/Ethnicity, Customized White Hispanic or Latino | 0 Participants |
| Race/Ethnicity, Customized White Not Hispanic or Latino | 3 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 3 / 3 |
| serious Total, serious adverse events | 1 / 3 |
Outcome results
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
Time frame: 3 months
Population: All participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| StrataGraft Skin Tissue | Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months | 100 percentage of participants |
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.
Time frame: 3 months
Population: All participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| StrataGraft Skin Tissue | Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months | Participant 1 | 100 percentage of treatment site |
| StrataGraft Skin Tissue | Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months | Participant 2 | 25 percentage of treatment site |
| StrataGraft Skin Tissue | Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months | Participant 3 | 125 percentage of treatment site |
Secondary
Cosmesis of Donor Sites at 3, 6, and 12 Months
Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance
Time frame: within 3, 6, and 12 Months
Population: Data were not collected
Secondary
Cosmesis of Treatment Sites at 3, 6, and 12 Months
Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance
Time frame: within 3, 6, and 12 Months
Population: Data were not collected
Secondary
Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months
Time frame: within 3, 6 and 12 months
Population: Data were not collected
Secondary
Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28
Time frame: at days 3, 7, 14, 21, and 28
Population: Data were not collected
Secondary
Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months
Time frame: within 3 months
Population: Data were not collected
Secondary
Percent Wound Closure at 3, 6, and 12 Months
Time frame: within 3, 6, and 12 Months
Population: Data were not collected