Cellulitis, Crush Injuries, Degloving Injuries, Full-thickness Skin Defects, Gun Shot Wound, Infection, Laceration of Skin, Necrotizing Fasciitis, Skin Cancer, Surgical Wound
Conditions
Brief summary
A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.
Interventions
PROCEDUREControl Intervention (Conventional Autograft)
Meshed split-thickness skin graft, with standardized wound dressings (Telfa™ Clear and Xeroform™)
DEVICEInvestigational Intervention (RECELL + more widely meshed autograft)
More widely meshed split-thickness skin graft, Spray-on Skin™ Cells prepared using RECELL, and standardized wound dressings (Telfa™ Clear and Xeroform™)
Sponsors
Avita Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
The participant and blinded evaluator will be not be told which treatment area received which treatment (RECELL or Control).
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient requires autografting for treatment of an acute full-thickness skin defect (e.g., trauma- or surgery-related). 2. The maximum area requiring autografting is 50% Total Body Surface Area (TBSA). 3. Two comparable areas requiring autografting, each at least 160 cm2 (or 320 cm2 contiguous), excluding face and genitalia. When hands or joints are included in the treatment areas, comparability of treatment areas means that each area (RECELL and Control) must include the same contralateral joint and/or hand. 4. The patient is at least 5 years of age. 5. The patient (or parent/guardian) is willing and able to comply with all compulsory study procedures and visit schedule. 6. The patient agrees to abstain from any other treatment (e.g., external fixation) of the study treatment areas for the duration of his/her participation the study (1 year). 7. The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation the study (1 year). 8. In the opinion of the investigator, the patient and/or guardian must be able to: 1. Understand the full nature and purpose of the study, including possible risks and adverse events, 2. Understand instructions, and 3. Provide voluntary informed written consent.
Exclusion criteria
1. Not able to understand English or Spanish. 2. The area requiring autografting sustained a burn injury. 3. The treatment area has previously failed to heal subsequent to surgical intervention for closure. 4. The patient is unable to follow the protocol requirements. 5. The patient has a condition that in the investigator's opinion may compromise patient safety or trial objectives. 6. Current use of medications that in the investigator's opinion may compromise patient safety or trial objectives. 7. The patient has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution. 8. The patient is pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements). 9. Life expectancy is less than 1 year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Area Healing | Prior to or at 8 weeks | The incidence of healing is hypothesized to be non-inferior for RECELL-treated areas (Investigational Intervention) as compared to Control areas (Control Intervention). Healing is defined as complete wound closure characterized by 100% skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a Blinded Evaluator. |
| Donor Skin Area to Treatment Area Expansion Ratio | Treatment Day | The donor skin expansion achieved with treatment using RECELL and widely meshed autograft (Investigational Intervention) is hypothesized to be superior to the donor skin expansion ratio achieved with conventional autograft treatment (Control Intervention). Expansion ratio, computed as the ratio of measured treated area to the measured donor site area, is calculated separately for each Intervention (including any donor skin needed for repeat treatments). |
Countries
United States
Participant flow
Pre-assignment details
The design of this study is a within-patient comparison. Protocol enrollment is 65 (participants), with 130 interventions (2 per participant).
Participants by arm
| Arm | Count |
|---|---|
| Experimental: All Participants (Within Patient Control) All subjects will receive both RECELL and skin graft. Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment (RECELL) will be randomly allocated to either Area A or Area B | 65 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 6 | 6 |
| Overall Study | Lost to Follow-up | 7 | 7 |
| Overall Study | Non-Compliance With Study Schedule | 2 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Experimental: All Participants (Within Patient Control) |
|---|---|
| Age, Continuous | 45.7 years STANDARD_DEVIATION 18.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 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 | 3 Participants |
| Race (NIH/OMB) White | 46 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 65 | 6 / 65 |
| other Total, other adverse events | 35 / 65 | 33 / 65 |
| serious Total, serious adverse events | 2 / 65 | 2 / 65 |
Outcome results
Primary
Donor Skin Area to Treatment Area Expansion Ratio
The donor skin expansion achieved with treatment using RECELL and widely meshed autograft (Investigational Intervention) is hypothesized to be superior to the donor skin expansion ratio achieved with conventional autograft treatment (Control Intervention). Expansion ratio, computed as the ratio of measured treated area to the measured donor site area, is calculated separately for each Intervention (including any donor skin needed for repeat treatments).
Time frame: Treatment Day
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Intervention | Donor Skin Area to Treatment Area Expansion Ratio | 1.39 Expansion Ratio | Standard Deviation 0.44 |
| Investigational Intervention (RECELL) | Donor Skin Area to Treatment Area Expansion Ratio | 1.86 Expansion Ratio | Standard Deviation 0.47 |
p-value: 0.001GMR of ratios
Primary
Incidence of Treatment Area Healing
The incidence of healing is hypothesized to be non-inferior for RECELL-treated areas (Investigational Intervention) as compared to Control areas (Control Intervention). Healing is defined as complete wound closure characterized by 100% skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a Blinded Evaluator.
Time frame: Prior to or at 8 weeks
Population: Per protocol
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Control Intervention | Incidence of Treatment Area Healing | 30 Treatment Areas |
| Investigational Intervention (RECELL) | Incidence of Treatment Area Healing | 34 Treatment Areas |
p-value: 0.0051-sided z-test of proportions