Burn, Thermal
Conditions
Keywords
Trauma-related wound, Deep partial thickness, Skin wound
Brief summary
About 70 participants will be enrolled. They will have complex skin defects because of burns caused by heat. The burns will: * be on 3-49% of the participant's total body surface area (TBSA) * require surgery for skin replacement * include intact dermal elements The burns are called deep, partial-thickness thermal burns because the skin was damaged by heat but still has some dermis that was not damaged. The dermis is the layer of skin under the outer layer (epidermis). It is the thickest layer of the skin that provides strength and flexibility to the skin. All patients will receive both treatments, but on different areas of their burns. Their wounds will not be compared to other patients. One treatment area on their own body will be compared to the other one. This will help to find out if StrataGraft is safe and effective for deep partial thickness burns. It will also see if StrataGraft might help healing enough to use it instead of the patient's own healthy skin to repair the damage.
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 burns. 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 burn 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 No maximum
Healthy volunteers
No
Inclusion criteria
Subject-specific criteria: 1. Men and women aged ≥ 18 years 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. Clinical expectation that the study donor site will heal without grafting 5. Complex skin defects of 3-49% TBSA * Total burn may consist of more than one area Treatment site-specific criteria: 6. Thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated 7. Total of both study treatment areas can be up to 2000 cm2 8. First excision and grafting of study treatment sites 9. Thermal burn(s) on the torso, arms, or legs
Exclusion criteria
Subject-specific criteria: 1. Pregnant women 2. Prisoners 3. Subjects receiving systemic immunosuppressive therapy 4. Subjects with a known history of malignancy 5. Preadmission insulin-dependent diabetic subjects 6. Subjects with concurrent conditions that in the opinion of the investigator may compromise subject safety or study objectives 7. Expected survival of less than three months 8. Participation in the treatment group of an interventional study within 90 days prior to enrollment Treatment site-specific criteria: 9. Full-thickness burns 10. Chronic wounds 11. The face, head, neck, hands, feet, buttocks, and area over joints 12. Treatment sites immediately adjacent to unexcised eschar 13. Clinical or laboratory determination of infection at the anticipated treatment sites
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Area of Treatment Sites Requiring Autografting by Month 3 | 3 Months | Percent area autografted by Month 3 is the sum of the percent areas at each study session/visit, up to and including Study Session 7/Month 3 (± 14 d). |
| Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3) | Month 3 | Wound closure of the treatment site was defined as complete skin re-epithelialization and the absence of drainage. A participant whose StrataGraft treatment site achieves durable wound closure without autograft placement is classified as a responder. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain at the Designated Donor Sites by Day 14 | Day 3, Day 7 and Day 14, average of the 3 days reported | Pain scores from the FACES scale range from 0 (no pain) to 5 (worst pain). Pain scores from Day 3, Day 7, and Day 14 (where available) are averaged for the summary statistics. |
| Total Scar Assessment (POSAS) Score by Observer at Month 3 | at Month 3 | Total Score is the sum of the scores for vascularization, pigmentation, thickness, relief, pliability, and surface area. For each of the 6 assessment categories, the scale ranged from 1=normal skin to 10=worst scar imaginable, with the highest possible score of 10. A higher score indicates worse scarring, so the best possible total score for the 6 categories is 6, and the worst possible score is 60. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants 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 burns. 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 burn wound. | 71 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 16 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants |
| Age, Continuous | 45 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 55 Participants |
| Region of Enrollment United States | 71 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 71 |
| other Total, other adverse events | 49 / 71 |
| serious Total, serious adverse events | 10 / 71 |
Outcome results
Primary
Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3)
Wound closure of the treatment site was defined as complete skin re-epithelialization and the absence of drainage. A participant whose StrataGraft treatment site achieves durable wound closure without autograft placement is classified as a responder.
Time frame: Month 3
Population: Modified Intent to Treat Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3) | 59 Participants |
95% CI: [74.4, 91.8]
Primary
Percent Area of Treatment Sites Requiring Autografting by Month 3
Percent area autografted by Month 3 is the sum of the percent areas at each study session/visit, up to and including Study Session 7/Month 3 (± 14 d).
Time frame: 3 Months
Population: Modified Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Percent Area of Treatment Sites Requiring Autografting by Month 3 | StrataGraft (Treatment) Sites | 4.33 percentage of treatment sites | Standard Deviation 21.58 |
| All Participants | Percent Area of Treatment Sites Requiring Autografting by Month 3 | Autograft (Control) Sites | 102.10 percentage of treatment sites | Standard Deviation 13.14 |
p-value: <0.0001one-sided Wilcoxin Signed RankTtest
Secondary
Pain at the Designated Donor Sites by Day 14
Pain scores from the FACES scale range from 0 (no pain) to 5 (worst pain). Pain scores from Day 3, Day 7, and Day 14 (where available) are averaged for the summary statistics.
Time frame: Day 3, Day 7 and Day 14, average of the 3 days reported
Population: Modified Intent to Treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Pain at the Designated Donor Sites by Day 14 | StrataGraft (Treatment) | 0.15 score on a scale | Standard Deviation 0.54 |
| All Participants | Pain at the Designated Donor Sites by Day 14 | Autograft (Control) | 2.55 score on a scale | Standard Deviation 1.3 |
p-value: <0.00011-sided, paired t-test
Secondary
Total Scar Assessment (POSAS) Score by Observer at Month 3
Total Score is the sum of the scores for vascularization, pigmentation, thickness, relief, pliability, and surface area. For each of the 6 assessment categories, the scale ranged from 1=normal skin to 10=worst scar imaginable, with the highest possible score of 10. A higher score indicates worse scarring, so the best possible total score for the 6 categories is 6, and the worst possible score is 60.
Time frame: at Month 3
Population: Maximum number of participants with data at Month 3 in the modified Intent to Treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Total Scar Assessment (POSAS) Score by Observer at Month 3 | StrataGraft (Treatment) | 6.3 score on a scale | Standard Deviation 1.71 |
| All Participants | Total Scar Assessment (POSAS) Score by Observer at Month 3 | Autograft (Control) | 16.3 score on a scale | Standard Deviation 7.71 |
p-value: <0.00011-sided, paired t-test