Burns
Conditions
Keywords
Pediatric, Burns, Partial-thickness
Brief summary
A prospective, parallel-arm, randomized (1:1) multicenter trial to demonstrate that RECELL treatment of partial-thickness burn injuries, can safely and effectively increase the incidence of Day 10 healing compared with a standardized wound dressing.
Interventions
DEVICERES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device
Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings.
COMBINATION_PRODUCTMepilex® Ag Wound Dressing
Application of Mepilex® Ag Wound Dressing
PROCEDUREConventional autografting (only when indicated)
When indicated, conventional autografting in accordance with Investigator's standard practice
Sponsors
Biomedical Advanced Research and Development Authority
Avita Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
1. Blinded Evaluator/Observer - local burn specialist 2. Independent Reviewer
Eligibility
Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patients aged 1 through 16 years (inclusive) with a partial-thickness thermal burn injury. 2. The patient has a thermal burn injury that is: 1. ≤ 30% TBSA (exclusive of superficial areas) and 2. ≤ 10% of the burn injury TBSA is a full-thickness burn. 3. The Index Burn must be a clean partial-thickness burn injury \> or = to 160 cm2 and between 2-20% BSA (inclusive). 4. The Index Burn may not cover the face, hand, foot or perineum/genitalia (Note: a patient with wounds in these areas may be enrolled but the Index Burn Area may not include these areas). 5. The patient and/or guardian agrees to comply with all compulsory study procedures and visit schedule. 6. The patient and/or parent/guardian agrees to abstain from any other treatment for closure of the Index Burn for the duration of the study, unless medically necessary. 7. The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study. 8. In the opinion of the investigator, the patient and/or parent/guardian must be able to: 1. Understand the full nature and purpose of the study, including possible risks and adverse events, 2. Understand instruction, and 3. Provide voluntary informed written consent/assent as appropriate for study participation.
Exclusion criteria
1. Not able to understand English or Spanish. 2. Burns caused by chemicals, electricity or radiation. 3. Patients presenting with only 3rd-degree/full-thickness wounds which require immediate autografting. 4. Burn injury has had prior treatment for definitive closure. 5. Patients for whom use of sedation/general anesthesia is not medically appropriate. 6. Superficial/trivial burns or burns that in the investigator's opinion appear to be healing sufficiently such that care under this protocol would be inappropriate. 7. Patient requires immediate or staged surgical procedures for closure of their partial-thickness burns. 8. Conditions, e.g., previous burn injury to study area, poor nutritional status, poorly controlled diabetes mellitus (HbA1c \>9%), that in the investigator's opinion may compromise subject safety or trial objectives. 9. Current use of medications, e.g., immunosuppressive agents (excluding inhaled corticosteroids), that in the investigator's opinion may compromise subject safety or trial objectives. 10. Inhalation injury. 11. Active infection, cellulitis or need for immediate grafting at the planned treatment areas. 12. Concerns for parent/guardian's ability to provide appropriate follow-up care. 13. Subjects with a known hypersensitivity to trypsin or compound sodium lactate for irrigation solution. 14. Subjects with a known sensitivity to silver. 15. In post-pubescent girls, pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements). 16. Immediate life-threatening condition or life expectancy less than one year. 17. Previous randomization within this investigation. Post-Randomization Inclusion Criteria (prior to treatment): 1. Patient randomized (and will be treated) within 72 hours from the time of the burn injury. 2. Patient continues to meet all pre-randomization inclusion criteria. Post-Randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Index Burns With Day 10 Healing | 10 Days post-treatment | Day 10 healing will be evaluated by an observer blinded to treatment allocation with confirmation at Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Day 21 Healing of the Index Burn | Day 21, confirmed on Day 28 | Incidence of Day 21 healing of the Index Burn confirmed on Day 28 |
| Incidence of Conventional Autografting to Achieve Healing of the Index Burn | Through Day 28 | Incidence of conventional autografting to achieve healing of the Index Burn |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RECELL® Autologous Cell Harvesting Device RECELL + Telfa™ Clear and Xeroform™ dressings
Conventional autografting (only when indicated)
RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings.
Conventional autografting (only when indicated): When indicated, conventional autografting in accordance with Investigator's standard practice | 13 |
| Mepilex® Ag Wound Dressing Mepilex® Ag Wound Dressing
Conventional autografting (only when indicated)
Mepilex® Ag Wound Dressing: Application of Mepilex® Ag Wound Dressing
Conventional autografting (only when indicated): When indicated, conventional autografting in accordance with Investigator's standard practice | 6 |
| Total | 19 |
Baseline characteristics
| Characteristic | RECELL® Autologous Cell Harvesting Device | Total | Mepilex® Ag Wound Dressing |
|---|---|---|---|
| Age, Continuous | 10.0 years STANDARD_DEVIATION 5.92 | 8.9 years STANDARD_DEVIATION 5.49 | 6.5 years STANDARD_DEVIATION 3.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 18 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 8 Participants | 3 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 | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 6 Participants | 7 Participants | 1 Participants |
| Region of Enrollment United States | 13 participants | 19 participants | 6 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 10 Participants | 13 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 6 |
| other Total, other adverse events | 6 / 13 | 3 / 6 |
| serious Total, serious adverse events | 1 / 13 | 1 / 6 |
Outcome results
Primary
Incidence of Index Burns With Day 10 Healing
Day 10 healing will be evaluated by an observer blinded to treatment allocation with confirmation at Day 28
Time frame: 10 Days post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RECELL® Autologous Cell Harvesting Device | Incidence of Index Burns With Day 10 Healing | 6 Participants |
| Mepilex® Ag Wound Dressing | Incidence of Index Burns With Day 10 Healing | 2 Participants |
Secondary
Incidence of Conventional Autografting to Achieve Healing of the Index Burn
Incidence of conventional autografting to achieve healing of the Index Burn
Time frame: Through Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RECELL® Autologous Cell Harvesting Device | Incidence of Conventional Autografting to Achieve Healing of the Index Burn | 0 Participants |
| Mepilex® Ag Wound Dressing | Incidence of Conventional Autografting to Achieve Healing of the Index Burn | 0 Participants |
Secondary
Incidence of Day 21 Healing of the Index Burn
Incidence of Day 21 healing of the Index Burn confirmed on Day 28
Time frame: Day 21, confirmed on Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RECELL® Autologous Cell Harvesting Device | Incidence of Day 21 Healing of the Index Burn | 7 Participants |
| Mepilex® Ag Wound Dressing | Incidence of Day 21 Healing of the Index Burn | 2 Participants |