Burns, Skin Wound, Trauma-related Wound
Conditions
Brief summary
Autografting is a surgical procedure to transplant healthy skin (donor skin) from another part of the participant's own body (donor site) to the burned part. Autografting is the usual treatment for DPT burns. It works to close the wound, but can cause other problems: * Donor sites are painful, can become infected or scarred, or can even become full thickness (FT) wounds themselves * Treatment problems can require more grafting * Additional surgery increases the risk of medical problems caused by the treatment Stratatech is trying to find a safe and effective alternative to autografting to promote the healing of severe burns. The purpose of this study was to evaluate whether StrataGraft treatment eliminates or reduces the need for autografting and promotes wound closure in a pediatric population with thermal burns that contain intact dermal elements and for which autografting is clinically indicated (DPT burns). Participants were enrolled into one of two age-based cohorts: 2 to \< 12 years and 12 to ≤ 17 years to receive a single application of StrataGraft, in up to 3 non-contiguous DPT burn areas located on the same extremity or plane of the torso.
Interventions
BIOLOGICALStrataGraft
StrataGraft® Construct
Sponsors
Biomedical Advanced Research and Development Authority
Stratatech, a Mallinckrodt Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent provided by the parent(s) or legal guardian(s) and assent from the child when appropriate * Have enough healthy skin to reserve as donor site(s), in case autografting becomes necessary * Thermal burns of no more than a total of 30% TBSA * Study treatment sites that are DPT in depth and which are clinically indicated for excision and autografting, and located on the torso or extremities * Study treatment area(s) totaling 0.5% to 10% TBSA and may be composed of up to 3 non-contiguous areas located on the same extremity or plane of the torso * Sufficient healthy skin available and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
Exclusion criteria
* Is pregnant or breastfeeding * Receiving treatment to suppress the immune system and/or systemic corticosteroids (inhaled corticosteroids are permitted) * A known history of malignancy * Pre-admission insulin-dependent diabetes * Concurrent trauma, conditions, and/or personal situations that, in the opinion of the investigator, may compromise the participant's safety or the study objectives * A burn injury that occurred ≥ 14 days prior to planned StrataGraft application Is expected to survive less than 12 months * Is participating in another interventional trial, or did within 90 days before enrollment * A proposed study treatment site that has been previously excised or autografted; located adjacent to an undebrided/unexcised burn area; demonstrates signs and symptoms of wound infection, per judgement of the clinical investigator; lies across joints or is located on the feet (i.e., distal to the malleolus), hands (distal to the wrist), face, neck, buttocks, perineum, or genitalia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Confirmed Complete Closure of StrataGraft Treatment Sites Without Autograft Within 12 Weeks of StrataGraft Application | Up to Week 12 | Confirmed complete wound closure is defined as complete skin re-epithelialization confirmed at 2 consecutive visits at least 2 weeks apart, but no later than Week 20. Percentage of participants whose burn healed after StrataGraft treatment without needing the doctor to treat the burn with skin cut from other parts of the patient's own body were reported. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to Month 12 | An adverse event (AE) is any untoward or undesirable medical occurrence in a participant who is administered a study treatment, which does not necessarily have to have a causal relationship with this treatment. TEAEs are AEs with an onset date on or after the start of StrataGraft treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of StrataGraft Treatment Sites Per Participant Closed at Week 12 Without Autograft Placement | At Week 12 | Wound closure was evaluated through visual inspection by the investigator. Complete wound closure was defined as complete re-epithelialization of the wound without drainage, confirmed at 2 consecutive visits at least 2 weeks apart. |
| Number of Confirmed Complete Wound Closures of the StrataGraft Treatment Sites on or Before Week 12 Without Autograft Placement | Up to Week 12 | Complete wound closure was defined as complete re-epithelialization of the wound without drainage, confirmed at two consecutive visits at least two weeks apart. |
| Mean of Averaged Percent Area of StrataGraft Treatment Sites Per Participant Autografted by Week 12 | Up to Week 12 | — |
Countries
United States
Participant flow
Recruitment details
Participant took part in the study at a single clinical site in the United States from 28 April 2023 to 9 May 2024.
Participants by arm
| Arm | Count |
|---|---|
| 2 to < 12 Years Age Group Cohort Single application of StrataGraft to 0.5% to 10% TBSA on Day 1. | 1 |
| 12 to ≤ 17 Years Age Group Cohort Single application of StrataGraft to 0.5% to 10% TBSA on Day 1. | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | 2 to < 12 Years Age Group Cohort | 12 to ≤ 17 Years Age Group Cohort | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 1 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant who is administered a study treatment, which does not necessarily have to have a causal relationship with this treatment. TEAEs are AEs with an onset date on or after the start of StrataGraft treatment.
Time frame: Up to Month 12
Population: Safety population included all participants who were enrolled and received StrataGraft.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2 to < 12 Years Age Group Cohort | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 1 Participants |
Primary
Percentage of Participants Who Achieved Confirmed Complete Closure of StrataGraft Treatment Sites Without Autograft Within 12 Weeks of StrataGraft Application
Confirmed complete wound closure is defined as complete skin re-epithelialization confirmed at 2 consecutive visits at least 2 weeks apart, but no later than Week 20. Percentage of participants whose burn healed after StrataGraft treatment without needing the doctor to treat the burn with skin cut from other parts of the patient's own body were reported.
Time frame: Up to Week 12
Population: Safety population included all participants who were enrolled and received StrataGraft.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 to < 12 Years Age Group Cohort | Percentage of Participants Who Achieved Confirmed Complete Closure of StrataGraft Treatment Sites Without Autograft Within 12 Weeks of StrataGraft Application | 100 percentage of participants |
Secondary
Mean of Averaged Percent Area of StrataGraft Treatment Sites Per Participant Autografted by Week 12
Time frame: Up to Week 12
Population: Safety population included all participants who were enrolled and received StrataGraft. None of the participant had StrataGraft treatment site that required autografting.
Secondary
Number of Confirmed Complete Wound Closures of the StrataGraft Treatment Sites on or Before Week 12 Without Autograft Placement
Complete wound closure was defined as complete re-epithelialization of the wound without drainage, confirmed at two consecutive visits at least two weeks apart.
Time frame: Up to Week 12
Population: Safety population included all participants who were enrolled and received StrataGraft.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 to < 12 Years Age Group Cohort | Number of Confirmed Complete Wound Closures of the StrataGraft Treatment Sites on or Before Week 12 Without Autograft Placement | 1 number of complete wound closure |
Secondary
Percentage of StrataGraft Treatment Sites Per Participant Closed at Week 12 Without Autograft Placement
Wound closure was evaluated through visual inspection by the investigator. Complete wound closure was defined as complete re-epithelialization of the wound without drainage, confirmed at 2 consecutive visits at least 2 weeks apart.
Time frame: At Week 12
Population: Safety population included all participants who were enrolled and received StrataGraft.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 to < 12 Years Age Group Cohort | Percentage of StrataGraft Treatment Sites Per Participant Closed at Week 12 Without Autograft Placement | 100 percentage of treatment sites |