Burns
Conditions
Brief summary
The overall purpose of this is study to provide continued access to the ReCell device following completion of protocol CTP001-6, and allow for collection of supplementary clinical outcome data for the ReCell device when used as an adjunct to meshed grafts in subjects with acute thermal burn injuries who require skin grafting for closure of burn injuries.
Interventions
DEVICEReCell
The ReCell-assigned treatment area will be treated as described in the product's Instructions for Use. In summary, 1ml of fluid physically covers a treatment area of 80 cm2. Each milliliter of fluid contains cells harvested from a square centimeter of thin split-thickness skin sample. The reagents and components of the ReCell kit are used, in a scalable fashion, to facilitate disaggregation of cells from skin samples into filtered cell suspension. Areas to be harvested for skin samples are to be clean and show no evidence of surrounding cellulitis or infection. Treatment area sizes and cell suspension volumes are to be recorded.
Sponsors
Avita Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject requires skin grafting as a result of an acute thermal burn injury (i.e. injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or water). 2. The area of total burn injury is 5-50% TBSA inclusive. 3. Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous), excluding hand/face and joints. 4. The subject is at least 5 years of age. 5. The subject (or family, for those under 18 years of age) is willing and able to complete all follow-up evaluations required by the study protocol. 6. The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary. 7. The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study. 8. The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent.
Exclusion criteria
1. The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances. 2. The subject is unable to follow the protocol. 3. The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives. 4. The subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution. 5. Life expectancy is less than 1year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority) | Prior to or at 8 weeks | Complete wound closure is defined as skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for ReCell-treated areas as compared to control areas. |
| Relative Reduction in Donor Skin Area Requirement | Prior to or at 8 weeks | For this second co-primary endpoint, it is hypothesized that the expansion ratio associated with the RECELL treatment area will be superior to that of the control, i.e. less donor skin will be required for RECELL-treated areas compared with the control areas. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental: All Participants (Within Patient Control) All subjects receive both ReCell treatment and autograft (Area A and Area B). Each subject serves as their own control. Wound regions were randomly assigned to receive an autograft consistent with the investigator's pre-identified graft plan (Control) or to receive application of the ReCell-generated cell suspension over an autograft more widely meshed than identified in the investigator's pre-specified graft plan (ReCell-treated). | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Experimental: All Participants (Within Patient Control) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 43.6 Years STANDARD_DEVIATION 12.93 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 7 / 12 |
| serious Total, serious adverse events | 2 / 12 |
Outcome results
Primary
Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)
Complete wound closure is defined as skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for ReCell-treated areas as compared to control areas.
Time frame: Prior to or at 8 weeks
Population: Per Protocol
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ReCell | Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority) | 9 Participants |
| Control | Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority) | 9 Participants |
Primary
Relative Reduction in Donor Skin Area Requirement
For this second co-primary endpoint, it is hypothesized that the expansion ratio associated with the RECELL treatment area will be superior to that of the control, i.e. less donor skin will be required for RECELL-treated areas compared with the control areas.
Time frame: Prior to or at 8 weeks
Population: Intent-to-Treat Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ReCell | Relative Reduction in Donor Skin Area Requirement | 2.1139 cm2 | Standard Deviation 2.2893 |
| Control | Relative Reduction in Donor Skin Area Requirement | 1.6523 cm2 | Standard Deviation 1.7578 |