Skin Wound, Burns, Trauma-related Wound
Conditions
Brief summary
The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the healing of the deep partial-thickness component of complex skin defects. The proposed study population will include patients with 3-49% Total Body Surface Area (TBSA) complex skin defects including a deep partial-thickness component resulting from thermal injury. The study has been designed to focus on the evaluation of safety and tolerability of prolonged exposure to increasing amounts of a single application of StrataGraft skin tissue, while also assessing the potential for StrataGraft tissue to promote healing of the deep partial-thickness component of these complex skin defects as an alternative to donor site harvesting and autografting. Targeted enrollment for this study is up to 30 patients with complex skin defects due to thermal burns which require surgical excision and autografting. Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving StrataGraft skin tissue that has been stored refrigerated prior to clinical use. A third cohort will receive StrataGraft skin tissue which has been stored cryopreserved and thawed in the operating room just prior to grafting.
Interventions
BIOLOGICALStrataGraft Skin Tissue
Sponsors
Stratatech, a Mallinckrodt Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Men and women aged 18-65 years, inclusive * Written informed consent * Sufficient healthy skin identified and designated as a donor site in the event that the StrataGraft treatment site requires autografting * Complex skin defects of 3-49% TBSA requiring excision and autografting * Total burn may consist of more than one wound area * Deep partial-thickness thermal burn(s) with total area of 88 to 880 cm2 requiring excision and autografting * First excision and grafting of treatment sites
Exclusion criteria
* Pregnant women and prisoners * Patients receiving systemic immunosuppressive therapy * Patients with a known history of malignancy * Preadmission insulin-dependent diabetic patients * Patients with concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives * Expected survival of less than three months * Participation in the treatment group of an interventional study within preceding 90 days prior to enrollment * Full-thickness burns will be excluded as treatment sites * Chronic wounds will be excluded as treatment sites * The face, head, neck, hands, feet, buttocks, and areas over joints will be excluded as treatment sites * Treatment sites adjacent to unexcised eschar * Clinical suspicion of burn wound infection at the anticipated treatment sites
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Wound Closure of the Treatment Sites at Three Months | 3 months | Determination of complete wound closure of both treatment sites was evaluated at 3 months. |
| Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28 | 28 days | The percentage of the treatment site area initially covered with StrataGraft tissue that required autograft by day 28 was determined. |
Countries
United States
Participant flow
Recruitment details
The study evaluated the safety and efficacy of StrataGraft skin tissue in promoting the healing of deep partial-thickness burns. Subjects had surgical excision and placement of StrataGraft skin tissue and autograft. The trial was conducted at six clinical sites throughout the United States.
Pre-assignment details
All subjects were treated with both StrataGraft skin tissue and autograft as part of the intrapatient comparator design. Two comparable excised areas of deep partial-thickness burn per subject were randomized to receive a single application of autograft or StrataGraft skin tissue.
Participants by arm
| Arm | Count |
|---|---|
| StrataGraft Skin Tissue : Autograft Two comparable deep partial-thickness burns were excised and randomized to receive StrataGraft skin tissue or autograft. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | StrataGraft Skin Tissue : Autograft |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 41.0 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 27 / 30 |
| serious Total, serious adverse events | 6 / 30 |
Outcome results
Primary
Number of Participants With Wound Closure of the Treatment Sites at Three Months
Determination of complete wound closure of both treatment sites was evaluated at 3 months.
Time frame: 3 months
Population: Intent-to-Treat (ITT) Population consisted of all participants who received any amount of StrataGraft skin tissue, regardless of follow-up status. Participants with available data were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| StrataGraft Skin Tissue | Number of Participants With Wound Closure of the Treatment Sites at Three Months | 29 Participants |
| Autograft | Number of Participants With Wound Closure of the Treatment Sites at Three Months | 29 Participants |
Primary
Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28
The percentage of the treatment site area initially covered with StrataGraft tissue that required autograft by day 28 was determined.
Time frame: 28 days
Population: ITT Population - consisted of all participants who received any amount of StrataGraft skin tissue, regardless of follow-up status.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| StrataGraft Skin Tissue | Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28 | 0 Percentage of area |