Burns
Conditions
Keywords
Second Degree Burn Injuries
Brief summary
This is a randomized, within-subject controlled study to compare the clinical performance of the ReCell device when used as an adjunct to meshed skin graft in subjects requiring skin grafts for closure of burn injuries. Co-primary effectiveness endpoints include: (1) confirmed treatment area closure (i.e., healing) prior to or at 8 weeks as assessed by a blinded evaluator, and (2) a comparison of the actual expansion ratio, computed as the ratio of measured treated area to the measured donor site area, achieved for the ReCell-treated and control treatment areas. Safety will be evaluated in terms of long-term durability, scar outcomes and treatment-related adverse events.
Interventions
DEVICEReCell Treatment
PROCEDURESkin Graft
Sponsors
MedDRA Assistance Inc
Advanced Clinical Research Services, LLC
Avita Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 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 followup 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 1 year.
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. |
| Actual Expansion Ratios (Treatment Area to Donor Site Area, Inclusive of Donor Skin Needed for Secondary Treatments) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observer Overall Patient and Observer Scar Assessment Scale ( POSAS) Opinion Score | At 24 Week | The observer component of the Patient and Observer Scar Assessment Scale (POSAS) questionnaire required the blinded evaluator to provide an overall opinion of the treatment area compared to normal skin, scored from 1 (normal skin) to 10 (worst imaginable scar). |
| Patient's Satisfaction/Treatment Preference | At 24 Week | — |
| Patient Overall Patient and Observer Scar Assessment Scale (POSAS) Opinion Score | Week 24 | The patient component of the Patient Overall Patient and Observer Scar Assessment Scale (POSAS) questionnaire required the patient to provide an overall opinion of the treatment area compared to normal skin, scored from 1 (normal skin) to 10 (worst imaginable scar). T |
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). | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Experimental: All Participants (Within Patient Control) |
|---|---|
| Age, Categorical <=18 years | 3 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age, Continuous | 39.1 years STANDARD_DEVIATION 15.84 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 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 | 20 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 30 |
| other Total, other adverse events | 26 / 30 |
| serious Total, serious adverse events | 12 / 30 |
Outcome results
Primary
Actual Expansion Ratios (Treatment Area to Donor Site Area, Inclusive of Donor Skin Needed for Secondary Treatments)
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 (primary analysis)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RECELL-Treated | Actual Expansion Ratios (Treatment Area to Donor Site Area, Inclusive of Donor Skin Needed for Secondary Treatments) | 1.9657 cm2 | Standard Deviation 2.0415 |
| Control | Actual Expansion Ratios (Treatment Area to Donor Site Area, Inclusive of Donor Skin Needed for Secondary Treatments) | 1.3486 cm2 | Standard Deviation 1.4143 |
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 Population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RECELL-Treated | Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority) | Confirmed Closure | 24 Participants |
| RECELL-Treated | Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority) | Not Healed | 2 Participants |
| Control | Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority) | Confirmed Closure | 22 Participants |
| Control | Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority) | Not Healed | 4 Participants |
Secondary
Observer Overall Patient and Observer Scar Assessment Scale ( POSAS) Opinion Score
The observer component of the Patient and Observer Scar Assessment Scale (POSAS) questionnaire required the blinded evaluator to provide an overall opinion of the treatment area compared to normal skin, scored from 1 (normal skin) to 10 (worst imaginable scar).
Time frame: At 24 Week
Population: Per-Protocol Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RECELL-Treated | Observer Overall Patient and Observer Scar Assessment Scale ( POSAS) Opinion Score | 2.6 units on a scale | Standard Deviation 1.2 |
| Control | Observer Overall Patient and Observer Scar Assessment Scale ( POSAS) Opinion Score | 2.5 units on a scale | Standard Deviation 1.42 |
Secondary
Patient Overall Patient and Observer Scar Assessment Scale (POSAS) Opinion Score
The patient component of the Patient Overall Patient and Observer Scar Assessment Scale (POSAS) questionnaire required the patient to provide an overall opinion of the treatment area compared to normal skin, scored from 1 (normal skin) to 10 (worst imaginable scar). T
Time frame: Week 24
Population: Per-Protocol Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RECELL-Treated | Patient Overall Patient and Observer Scar Assessment Scale (POSAS) Opinion Score | 5.2 units on a scale | Standard Deviation 2.76 |
| Control | Patient Overall Patient and Observer Scar Assessment Scale (POSAS) Opinion Score | 5.1 units on a scale | Standard Deviation 2.96 |
Secondary
Patient's Satisfaction/Treatment Preference
Time frame: At 24 Week
Population: Per-Protocol Population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RECELL-Treated | Patient's Satisfaction/Treatment Preference | Preferred RECELL | 12 Participants |
| RECELL-Treated | Patient's Satisfaction/Treatment Preference | Preferred CONTROL | 12 Participants |
| RECELL-Treated | Patient's Satisfaction/Treatment Preference | No Preference | 2 Participants |