Trial Outcomes & Findings for A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries (NCT NCT01138917)

Last Updated: 2019-05-13

Results Overview

Recipient site wound closure for both ReCell and STMSG will be defined as the presence of \>=95% epithelialization with contiguous layer of viable epithelium without the need for secondary surgical intervention. Factors considered during the assessment included color, presence of granulation tissue, and whether or not the entire wound is covered with a contiguous layer of viable epithelium. Using this definition, some small degree of punctate blistering was acceptable as long as the wound was \>=95% epithelialized.

Recruitment status

COMPLETED

Study phase

Target enrollment

101 participants

Primary outcome timeframe

4 weeks

Results posted on

2019-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental: All Participants (Within Patient Control) Every subject received both interventions (RECELL and Control (2:1 meshed split-thickness autograft)). Two distinct but similar areas of burn injury at least 100 cm2 and second degree depth will be treated according to random assignment (Area A and Area B). One burn injury area receives RECELL (Investigational Treatment) and the other area Control (2:1 meshed autograft).
Overall Study STARTED	101
Overall Study COMPLETED	77
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: All Participants (Within Patient Control) n=101 Participants Every subject received both interventions (RECELL and 2:1 meshed split-thickness autograft). Two distinct but similar areas of burn injury at least 100 cm2 and second degree depth will be treated according to random assignment (Area A and Area B). One burn injury area receives RECELL (Investigational Treatment) and the other area 2:1 meshed autograft (Control).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	101 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39.5 years STANDARD_DEVIATION 13.06 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	85 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	59 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic	19 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	20 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=5 Participants
Region of Enrollment United States	101 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Analysis to evaluate non-inferiority of recipient site wound closure was performed on the ITT, PP, and MPP populations.

Outcome measures

Outcome measures
Measure	RECELL n=101 Participants Cell suspension prepared using the RECELL device applied to "RECELL Recipient Site"	Control n=101 Participants 2:1 meshed autograft applied to "Control Recipient Site"
Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority) Per Protocol Population (PP)	82 Participants	87 Participants
Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority) Modified Per Protocol Population (MPP)	82 Participants	83 Participants
Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority) Intent to Treat (ITT)	84 Participants	97 Participants

PRIMARY outcome

Timeframe: 1 week

Population: Analysis was performed on ITT, PP, and MPP populations. Note: The number of participants with evaluable donor sites differs than number of participants with evaluable recipient sites.

Donor site healing will be considered as complete (100%) wound closure if the following criteria were met: an ability to separate the dressing from the wound bed with visible presence over the entirety of the wound of dry, opalescent-pink external surface representing the newly formed outer cornfield layer of the epidermis.

Outcome measures

Outcome measures
Measure	RECELL n=100 Participants Cell suspension prepared using the RECELL device applied to "RECELL Recipient Site"	Control n=100 Participants 2:1 meshed autograft applied to "Control Recipient Site"
Incidence of RECELL Donor Site Healing Compared to Control at 1 Week (Superiority) Intent to Treat (ITT)	22 Participants	10 Participants
Incidence of RECELL Donor Site Healing Compared to Control at 1 Week (Superiority) Per Protocol (PP)	19 Participants	10 Participants
Incidence of RECELL Donor Site Healing Compared to Control at 1 Week (Superiority) Modified Per Protocol (MPP)	18 Participants	10 Participants

SECONDARY outcome

Timeframe: Each visit through Week 16

Population: Percent Epithelialization presented for Per Protocol Population (PP) based on subjects presented for healing evaluation per visit

The percent epithelialization of the RECELL and Control treated sites will be assessed using standardized planimetry/tracing procedures. The tracings were uploaded to a Central Reading Facility for calculation of percent epithelialization using a computerized measurement technique.

Outcome measures

Outcome measures
Measure	RECELL n=87 Participants Cell suspension prepared using the RECELL device applied to "RECELL Recipient Site"	Control n=87 Participants 2:1 meshed autograft applied to "Control Recipient Site"
Percent of Epithelialization at Each Visit Through Week 16 % Epithelialization - Week 1	66.1 percentage of epithelialization Standard Deviation 40.94	74.0 percentage of epithelialization Standard Deviation 41.25
Percent of Epithelialization at Each Visit Through Week 16 % Epithelialization - Week 2	92.1 percentage of epithelialization Standard Deviation 20.38	99.8 percentage of epithelialization Standard Deviation 1.16
Percent of Epithelialization at Each Visit Through Week 16 % Epithelialization - Week 3	95.8 percentage of epithelialization Standard Deviation 14.90	99.9 percentage of epithelialization Standard Deviation 0.58
Percent of Epithelialization at Each Visit Through Week 16 % Epithelialization - Week 4	97.7 percentage of epithelialization Standard Deviation 11.98	100.0 percentage of epithelialization Standard Deviation 0.07
Percent of Epithelialization at Each Visit Through Week 16 % Epithelialization - Week 8	99.8 percentage of epithelialization Standard Deviation 1.42	100.0 percentage of epithelialization Standard Deviation 0.00
Percent of Epithelialization at Each Visit Through Week 16 % Epithelialization - Week 16	100.0 percentage of epithelialization Standard Deviation 0.00	100.0 percentage of epithelialization Standard Deviation 0.00

SECONDARY outcome

Timeframe: Week 2

The proportion of recipient sites achieving wound closure at Week 2 was evaluated using the Investigators assessment of wound healing.

Outcome measures

Outcome measures
Measure	RECELL n=87 Participants Cell suspension prepared using the RECELL device applied to "RECELL Recipient Site"	Control 2:1 meshed autograft applied to "Control Recipient Site"
Wound Closure at Week 2 (Based on Investigators Assessment) RECELL and Control Healed	70 Participants	—
Wound Closure at Week 2 (Based on Investigators Assessment) RECELL Healed and Control Not Healed	1 Participants	—
Wound Closure at Week 2 (Based on Investigators Assessment) RECELL Not Healed and Control Healed	16 Participants	—
Wound Closure at Week 2 (Based on Investigators Assessment) RECELL and Control Not Healed	0 Participants	—

SECONDARY outcome

Timeframe: Pain (Weeks 1-16) and Appearance (Weeks 16-52)

Population: Per-Protocol Population

Subject assessment of pain at the RECELL and Control recipient sites was performed at all study follow-up visits up to Week 16. Subjects also assessed the satisfaction with the appearance of the treatment sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires. Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional

Outcome measures

Outcome measures
Measure	RECELL n=87 Participants Cell suspension prepared using the RECELL device applied to "RECELL Recipient Site"	Control n=87 Participants 2:1 meshed autograft applied to "Control Recipient Site"
Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment) Mean Pain Scores at Week 1	24.1 Scores on a Scale (0-100) Standard Deviation 23.31	26.5 Scores on a Scale (0-100) Standard Deviation 24.58
Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment) Mean Pain Scores at Week 2	12.4 Scores on a Scale (0-100) Standard Deviation 19.42	12.4 Scores on a Scale (0-100) Standard Deviation 19.10
Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment) Mean Pain Scores at Week 3	9.6 Scores on a Scale (0-100) Standard Deviation 14.39	7.9 Scores on a Scale (0-100) Standard Deviation 14.60
Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment) Mean Pain Scores at Week 4	6.9 Scores on a Scale (0-100) Standard Deviation 12.64	6.7 Scores on a Scale (0-100) Standard Deviation 12.25
Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment) Mean Pain Scores at Week 8	7.6 Scores on a Scale (0-100) Standard Deviation 16.94	8.8 Scores on a Scale (0-100) Standard Deviation 18.46
Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment) Mean Pain Scores at Week 16	3.3 Scores on a Scale (0-100) Standard Deviation 8.15	4.3 Scores on a Scale (0-100) Standard Deviation 10.56
Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment) Mean Visual Appearance Week 16	77.7 Scores on a Scale (0-100) Standard Deviation 23.96	75.6 Scores on a Scale (0-100) Standard Deviation 24.18
Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment) Mean Visual Appearance Week 24	82.6 Scores on a Scale (0-100) Standard Deviation 22.82	79.4 Scores on a Scale (0-100) Standard Deviation 22.78
Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment) Mean Visual Appearance Week 52	83.1 Scores on a Scale (0-100) Standard Deviation 22.07	80.1 Scores on a Scale (0-100) Standard Deviation 19.73

SECONDARY outcome

Timeframe: Pain (Weeks 1-16) and Appearance (Weeks 16-52)

Population: Per-Protocol Population

Subject assessment of pain at the RECELL and Control donor sites was performed at all study follow-up visits up to Week 16. Subjects also assessed the satisfaction with the appearance of the donor sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires. Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional.

Outcome measures

Outcome measures
Measure	RECELL n=87 Participants Cell suspension prepared using the RECELL device applied to "RECELL Recipient Site"	Control n=87 Participants 2:1 meshed autograft applied to "Control Recipient Site"
Mean Pain and Appearance Scores at Donor Sites (Subject Assessment) Mean Pain Scores at Week 1	21.9 Scores on a Scale (0-100) Standard Deviation 26.35	43.5 Scores on a Scale (0-100) Standard Deviation 29.43
Mean Pain and Appearance Scores at Donor Sites (Subject Assessment) Mean Pain Scores at Week 2	5.1 Scores on a Scale (0-100) Standard Deviation 11.25	19.3 Scores on a Scale (0-100) Standard Deviation 24.42
Mean Pain and Appearance Scores at Donor Sites (Subject Assessment) Mean Pain Scores at Week 3	1.9 Scores on a Scale (0-100) Standard Deviation 3.87	9.4 Scores on a Scale (0-100) Standard Deviation 19.14
Mean Pain and Appearance Scores at Donor Sites (Subject Assessment) Mean Pain Scores at Week 4	1.9 Scores on a Scale (0-100) Standard Deviation 5.84	5.2 Scores on a Scale (0-100) Standard Deviation 12.07
Mean Pain and Appearance Scores at Donor Sites (Subject Assessment) Mean Pain Scores at Week 8	1.4 Scores on a Scale (0-100) Standard Deviation 2.78	3.7 Scores on a Scale (0-100) Standard Deviation 9.97
Mean Pain and Appearance Scores at Donor Sites (Subject Assessment) Mean Pain Scores at Week 16	0.9 Scores on a Scale (0-100) Standard Deviation 1.61	1.5 Scores on a Scale (0-100) Standard Deviation 2.84
Mean Pain and Appearance Scores at Donor Sites (Subject Assessment) Mean Visual Appearance Week 16	89.8 Scores on a Scale (0-100) Standard Deviation 16.87	75.1 Scores on a Scale (0-100) Standard Deviation 26.36
Mean Pain and Appearance Scores at Donor Sites (Subject Assessment) Mean Visual Appearance Week 24	93.4 Scores on a Scale (0-100) Standard Deviation 9.96	81.1 Scores on a Scale (0-100) Standard Deviation 21.55
Mean Pain and Appearance Scores at Donor Sites (Subject Assessment) Mean Visual Appearance Week 52	91.2 Scores on a Scale (0-100) Standard Deviation 14.84	83.3 Scores on a Scale (0-100) Standard Deviation 18.62

Adverse Events

Experimental: All Participants (Within Patient Control)

Serious events: 10 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Experimental: All Participants (Within Patient Control) n=101 participants at risk All subjects received cell suspension prepared using the RECELL device applied to "RECELL Recipient Site" and 2:1 meshed conventional autografting applied to "Control Recipient Site"
Gastrointestinal disorders Nausea, Vomiting, Diarrhea	0.99% 1/101 • Number of events 1 • All adverse events occurring during the course of the clinical study were reported. Adverse event reporting was limited to wound findings, i.e. scarring, contraction, etc. of the study wound areas at Week 16 through to Week 52. The number of specific adverse events that occurred per wound area is included in the Adverse Event Term Additional Description.
Vascular disorders Blood clot detected in left leg	0.99% 1/101 • Number of events 1 • All adverse events occurring during the course of the clinical study were reported. Adverse event reporting was limited to wound findings, i.e. scarring, contraction, etc. of the study wound areas at Week 16 through to Week 52. The number of specific adverse events that occurred per wound area is included in the Adverse Event Term Additional Description.
Injury, poisoning and procedural complications Scar contracture release	0.99% 1/101 • Number of events 1 • All adverse events occurring during the course of the clinical study were reported. Adverse event reporting was limited to wound findings, i.e. scarring, contraction, etc. of the study wound areas at Week 16 through to Week 52. The number of specific adverse events that occurred per wound area is included in the Adverse Event Term Additional Description.
Injury, poisoning and procedural complications >10% graft loss	0.99% 1/101 • Number of events 1 • All adverse events occurring during the course of the clinical study were reported. Adverse event reporting was limited to wound findings, i.e. scarring, contraction, etc. of the study wound areas at Week 16 through to Week 52. The number of specific adverse events that occurred per wound area is included in the Adverse Event Term Additional Description.
Injury, poisoning and procedural complications Burn wound excision/grafting	0.99% 1/101 • Number of events 1 • All adverse events occurring during the course of the clinical study were reported. Adverse event reporting was limited to wound findings, i.e. scarring, contraction, etc. of the study wound areas at Week 16 through to Week 52. The number of specific adverse events that occurred per wound area is included in the Adverse Event Term Additional Description.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.99% 1/101 • Number of events 1 • All adverse events occurring during the course of the clinical study were reported. Adverse event reporting was limited to wound findings, i.e. scarring, contraction, etc. of the study wound areas at Week 16 through to Week 52. The number of specific adverse events that occurred per wound area is included in the Adverse Event Term Additional Description.
Injury, poisoning and procedural complications New burn injury	0.99% 1/101 • Number of events 1 • All adverse events occurring during the course of the clinical study were reported. Adverse event reporting was limited to wound findings, i.e. scarring, contraction, etc. of the study wound areas at Week 16 through to Week 52. The number of specific adverse events that occurred per wound area is included in the Adverse Event Term Additional Description.
Infections and infestations Suspected wound infection	0.99% 1/101 • Number of events 1 • All adverse events occurring during the course of the clinical study were reported. Adverse event reporting was limited to wound findings, i.e. scarring, contraction, etc. of the study wound areas at Week 16 through to Week 52. The number of specific adverse events that occurred per wound area is included in the Adverse Event Term Additional Description.
Injury, poisoning and procedural complications Graft failure conversion to full thickness wound	0.99% 1/101 • Number of events 1 • All adverse events occurring during the course of the clinical study were reported. Adverse event reporting was limited to wound findings, i.e. scarring, contraction, etc. of the study wound areas at Week 16 through to Week 52. The number of specific adverse events that occurred per wound area is included in the Adverse Event Term Additional Description.
Injury, poisoning and procedural complications Coumadin toxicity	0.99% 1/101 • Number of events 1 • All adverse events occurring during the course of the clinical study were reported. Adverse event reporting was limited to wound findings, i.e. scarring, contraction, etc. of the study wound areas at Week 16 through to Week 52. The number of specific adverse events that occurred per wound area is included in the Adverse Event Term Additional Description.
Blood and lymphatic system disorders Worsening anemia post-operatively	0.99% 1/101 • Number of events 1 • All adverse events occurring during the course of the clinical study were reported. Adverse event reporting was limited to wound findings, i.e. scarring, contraction, etc. of the study wound areas at Week 16 through to Week 52. The number of specific adverse events that occurred per wound area is included in the Adverse Event Term Additional Description.
Cardiac disorders Intraoperative tachycardia resolved with fluids and beta-blockade	0.99% 1/101 • Number of events 1 • All adverse events occurring during the course of the clinical study were reported. Adverse event reporting was limited to wound findings, i.e. scarring, contraction, etc. of the study wound areas at Week 16 through to Week 52. The number of specific adverse events that occurred per wound area is included in the Adverse Event Term Additional Description.

Other adverse events

Other adverse events
Measure	Experimental: All Participants (Within Patient Control) n=101 participants at risk All subjects received cell suspension prepared using the RECELL device applied to "RECELL Recipient Site" and 2:1 meshed conventional autografting applied to "Control Recipient Site"
Skin and subcutaneous tissue disorders Hypertrophic Scar	14.9% 15/101 • Number of events 26 • All adverse events occurring during the course of the clinical study were reported. Adverse event reporting was limited to wound findings, i.e. scarring, contraction, etc. of the study wound areas at Week 16 through to Week 52. The number of specific adverse events that occurred per wound area is included in the Adverse Event Term Additional Description.
Skin and subcutaneous tissue disorders Rash	5.0% 5/101 • Number of events 6 • All adverse events occurring during the course of the clinical study were reported. Adverse event reporting was limited to wound findings, i.e. scarring, contraction, etc. of the study wound areas at Week 16 through to Week 52. The number of specific adverse events that occurred per wound area is included in the Adverse Event Term Additional Description.
Skin and subcutaneous tissue disorders Hypergranulated Tissue/Hypergranulation	6.9% 7/101 • Number of events 10 • All adverse events occurring during the course of the clinical study were reported. Adverse event reporting was limited to wound findings, i.e. scarring, contraction, etc. of the study wound areas at Week 16 through to Week 52. The number of specific adverse events that occurred per wound area is included in the Adverse Event Term Additional Description.
Skin and subcutaneous tissue disorders Itching/Pruritus	5.9% 6/101 • Number of events 14 • All adverse events occurring during the course of the clinical study were reported. Adverse event reporting was limited to wound findings, i.e. scarring, contraction, etc. of the study wound areas at Week 16 through to Week 52. The number of specific adverse events that occurred per wound area is included in the Adverse Event Term Additional Description.
General disorders Hypertrophy	6.9% 7/101 • Number of events 13 • All adverse events occurring during the course of the clinical study were reported. Adverse event reporting was limited to wound findings, i.e. scarring, contraction, etc. of the study wound areas at Week 16 through to Week 52. The number of specific adverse events that occurred per wound area is included in the Adverse Event Term Additional Description.

Additional Information

Director of 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