Trial Outcomes & Findings for CONTINUED ACCESS PROTOCOL: Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries (NCT NCT02994654)

Last Updated: 2024-07-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

Prior to or at 8 weeks

Results posted on

2024-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental: All Participants (Within Patient Control) Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control. Each subject's study treatment area (burn injury) was divided into Area A and Area B before the areas (A and B) were randomly assigned to receive CONTROL (grafting consistent with the pre-identified graft plan) or RECELL (RECELL-generated cell suspension applied over a graft more widely meshed than identified in the pre-specified graft plan).
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: All Participants (Within Patient Control) Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control. Each subject's study treatment area (burn injury) was divided into Area A and Area B before the areas (A and B) were randomly assigned to receive CONTROL (grafting consistent with the pre-identified graft plan) or RECELL (RECELL-generated cell suspension applied over a graft more widely meshed than identified in the pre-specified graft plan).
Overall Study Lost to Follow-up	1

Baseline Characteristics

CONTINUED ACCESS PROTOCOL: Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: All Participants (Within Patient Control) n=12 Participants 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).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	43.6 Years STANDARD_DEVIATION 12.93 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Prior to or at 8 weeks

Population: Per Protocol

Outcome measures

Outcome measures
Measure	ReCell n=9 Participants All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B ReCell: 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.	Control n=9 Participants All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Control, which is the Investigator's pre-determined graft plan will be randomly allocated to either Area A or Area B ReCell: 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.
Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)	9 Participants	9 Participants

PRIMARY outcome

Timeframe: Prior to or at 8 weeks

Population: Intent-to-Treat Population

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.

Outcome measures

Outcome measures
Measure	ReCell n=12 Participants All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B ReCell: 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.	Control n=12 Participants All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Control, which is the Investigator's pre-determined graft plan will be randomly allocated to either Area A or Area B ReCell: 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.
Relative Reduction in Donor Skin Area Requirement	2.1139 cm2 Standard Deviation 2.2893	1.6523 cm2 Standard Deviation 1.7578

Adverse Events

All Participants

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Participants n=12 participants at risk 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).
Injury, poisoning and procedural complications Failed Skin Graft	8.3% 1/12 • Number of events 1 • 52 Weeks
Injury, poisoning and procedural complications Delayed Wound Healing	8.3% 1/12 • Number of events 1 • 52 Weeks
Injury, poisoning and procedural complications Respiratory Distress	8.3% 1/12 • Number of events 2 • 52 Weeks

Other adverse events

Other adverse events
Measure	All Participants n=12 participants at risk 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).
Injury, poisoning and procedural complications Failed Skin Graft	8.3% 1/12 • Number of events 1 • 52 Weeks
General disorders Delayed Wound Healing	8.3% 1/12 • Number of events 1 • 52 Weeks
Injury, poisoning and procedural complications Graft Loss Left Abdomen	8.3% 1/12 • Number of events 1 • 52 Weeks
General disorders Non-healing Burn Wound	8.3% 1/12 • Number of events 1 • 52 Weeks
Vascular disorders Severe Intermittent Nerve Pain	8.3% 1/12 • Number of events 1 • 52 Weeks
Injury, poisoning and procedural complications Graft Loss Right Abdomen	8.3% 1/12 • Number of events 1 • 52 Weeks
Injury, poisoning and procedural complications Right Thigh Graft Loss	8.3% 1/12 • Number of events 1 • 52 Weeks
Injury, poisoning and procedural complications Graft Loss Left Upper Arm	8.3% 1/12 • Number of events 1 • 52 Weeks
Injury, poisoning and procedural complications Hypertrophic Scar	8.3% 1/12 • Number of events 1 • 52 Weeks
Respiratory, thoracic and mediastinal disorders Respiratory Distress	8.3% 1/12 • Number of events 2 • 52 Weeks

Additional Information

VP Clinical Research

AVITA Medical

Phone: 661-367-9170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place