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

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ClinicalTrials.gov Identifier: NCT01138917
Recruitment Status : Completed
First Posted : June 8, 2010
Results First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Sponsor:
Collaborators:
United States Department of Defense
Royal Perth Hospital
MedDRA Assistance Inc
BioStat International, Inc.
Information provided by (Responsible Party):
Avita Medical

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Burns
Intervention Device: ReCell and Split-thickness skin graft
Enrollment 101
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Experimental: All Participants (Within Patient Control)
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 101
Completed 77
Not Completed 24
Arm/Group Title Experimental: All Participants (Within Patient Control)
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
<=18 years
0
   0.0%
Between 18 and 65 years
101
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants
39.5  (13.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
Female
16
  15.8%
Male
85
  84.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 101 participants
White
59
  58.4%
Hispanic
19
  18.8%
Asian
1
   1.0%
American Indian
0
   0.0%
Black
20
  19.8%
Other
2
   2.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 101 participants
101
1.Primary Outcome
Title Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority)
Hide Description 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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis to evaluate non-inferiority of recipient site wound closure was performed on the ITT, PP, and MPP populations.
Arm/Group Title RECELL Control
Hide Arm/Group Description:
Cell suspension prepared using the RECELL device applied to "RECELL Recipient Site"
2:1 meshed autograft applied to "Control Recipient Site"
Overall Number of Participants Analyzed 101 101
Measure Type: Count of Participants
Unit of Measure: Participants
Per Protocol Population (PP) Number Analyzed 87 participants 87 participants
82
  94.3%
87
 100.0%
Modified Per Protocol Population (MPP) Number Analyzed 83 participants 83 participants
82
  98.8%
83
 100.0%
Intent to Treat (ITT) Number Analyzed 101 participants 101 participants
84
  83.2%
97
  96.0%
2.Primary Outcome
Title Incidence of RECELL Donor Site Healing Compared to Control at 1 Week (Superiority)
Hide Description 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.
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title RECELL Control
Hide Arm/Group Description:
RECELL donor site
Control donor site
Overall Number of Participants Analyzed 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
Intent to Treat (ITT) Number Analyzed 100 participants 100 participants
22
  22.0%
10
  10.0%
Per Protocol (PP) Number Analyzed 88 participants 88 participants
19
  21.6%
10
  11.4%
Modified Per Protocol (MPP) Number Analyzed 82 participants 82 participants
18
  22.0%
10
  12.2%
3.Secondary Outcome
Title Percent of Epithelialization at Each Visit Through Week 16
Hide Description 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.
Time Frame Each visit through Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Percent Epithelialization presented for Per Protocol Population (PP) based on subjects presented for healing evaluation per visit
Arm/Group Title RECELL Control
Hide Arm/Group Description:
Cell suspension prepared using the RECELL device applied to "RECELL Recipient Site"
2:1 meshed autograft applied to "Control Recipient Site"
Overall Number of Participants Analyzed 87 87
Mean (Standard Deviation)
Unit of Measure: percentage of epithelialization
% Epithelialization - Week 1 Number Analyzed 83 participants 84 participants
66.1  (40.94) 74.0  (41.25)
% Epithelialization - Week 2 Number Analyzed 87 participants 87 participants
92.1  (20.38) 99.8  (1.16)
% Epithelialization - Week 3 Number Analyzed 84 participants 85 participants
95.8  (14.90) 99.9  (0.58)
% Epithelialization - Week 4 Number Analyzed 87 participants 87 participants
97.7  (11.98) 100.0  (0.07)
% Epithelialization - Week 8 Number Analyzed 86 participants 86 participants
99.8  (1.42) 100.0  (0.00)
% Epithelialization - Week 16 Number Analyzed 87 participants 87 participants
100.0  (0.00) 100.0  (0.00)
4.Secondary Outcome
Title Wound Closure at Week 2 (Based on Investigators Assessment)
Hide Description The proportion of recipient sites achieving wound closure at Week 2 was evaluated using the Investigators assessment of wound healing.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recipient Site Wound Healing at Week 2
Hide Arm/Group Description:
Investigator Assessment of Recipient Site Wound Healing Per-Protocol Population
Overall Number of Participants Analyzed 87
Measure Type: Count of Participants
Unit of Measure: Participants
RECELL and Control Healed
70
  80.5%
RECELL Healed and Control Not Healed
1
   1.1%
RECELL Not Healed and Control Healed
16
  18.4%
RECELL and Control Not Healed
0
   0.0%
5.Secondary Outcome
Title Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment)
Hide Description

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

Time Frame Pain (Weeks 1-16) and Appearance (Weeks 16-52)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population
Arm/Group Title RECELL Control
Hide Arm/Group Description:
Cell suspension prepared using the RECELL device applied to "RECELL Recipient Site"
2:1 meshed autograft applied to "Control Recipient Site"
Overall Number of Participants Analyzed 87 87
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale (0-100)
Mean Pain Scores at Week 1 Number Analyzed 80 participants 80 participants
24.1  (23.31) 26.5  (24.58)
Mean Pain Scores at Week 2 Number Analyzed 85 participants 85 participants
12.4  (19.42) 12.4  (19.10)
Mean Pain Scores at Week 3 Number Analyzed 85 participants 85 participants
9.6  (14.39) 7.9  (14.60)
Mean Pain Scores at Week 4 Number Analyzed 87 participants 87 participants
6.9  (12.64) 6.7  (12.25)
Mean Pain Scores at Week 8 Number Analyzed 86 participants 86 participants
7.6  (16.94) 8.8  (18.46)
Mean Pain Scores at Week 16 Number Analyzed 81 participants 81 participants
3.3  (8.15) 4.3  (10.56)
Mean Visual Appearance Week 16 Number Analyzed 83 participants 83 participants
77.7  (23.96) 75.6  (24.18)
Mean Visual Appearance Week 24 Number Analyzed 72 participants 72 participants
82.6  (22.82) 79.4  (22.78)
Mean Visual Appearance Week 52 Number Analyzed 70 participants 70 participants
83.1  (22.07) 80.1  (19.73)
6.Secondary Outcome
Title Mean Pain and Appearance Scores at Donor Sites (Subject Assessment)
Hide Description

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.

Time Frame Pain (Weeks 1-16) and Appearance (Weeks 16-52)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population
Arm/Group Title RECELL Control
Hide Arm/Group Description:
RECELL donor site
Control donor site
Overall Number of Participants Analyzed 87 87
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale (0-100)
Mean Pain Scores at Week 1 Number Analyzed 80 participants 80 participants
21.9  (26.35) 43.5  (29.43)
Mean Pain Scores at Week 2 Number Analyzed 85 participants 85 participants
5.1  (11.25) 19.3  (24.42)
Mean Pain Scores at Week 3 Number Analyzed 85 participants 85 participants
1.9  (3.87) 9.4  (19.14)
Mean Pain Scores at Week 4 Number Analyzed 87 participants 87 participants
1.9  (5.84) 5.2  (12.07)
Mean Pain Scores at Week 8 Number Analyzed 86 participants 86 participants
1.4  (2.78) 3.7  (9.97)
Mean Pain Scores at Week 16 Number Analyzed 81 participants 81 participants
0.9  (1.61) 1.5  (2.84)
Mean Visual Appearance Week 16 Number Analyzed 83 participants 83 participants
89.8  (16.87) 75.1  (26.36)
Mean Visual Appearance Week 24 Number Analyzed 72 participants 72 participants
93.4  (9.96) 81.1  (21.55)
Mean Visual Appearance Week 52 Number Analyzed 70 participants 70 participants
91.2  (14.84) 83.3  (18.62)
Time Frame 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.
Adverse Event Reporting Description The number of specific adverse events that occurred per wound area is included in the Adverse Event Term Additional Description.
 
Arm/Group Title Experimental: All Participants (Within Patient Control)
Hide Arm/Group Description 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"
All-Cause Mortality
Experimental: All Participants (Within Patient Control)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Experimental: All Participants (Within Patient Control)
Affected / at Risk (%) # Events
Total   10/101 (9.90%)    
Blood and lymphatic system disorders   
Worsening anemia post-operatively   1/101 (0.99%)  1
Cardiac disorders   
Intraoperative tachycardia resolved with fluids and beta-blockade   1/101 (0.99%)  1
Gastrointestinal disorders   
Nausea, Vomiting, Diarrhea   1/101 (0.99%)  1
Infections and infestations   
Suspected wound infection  [1]  1/101 (0.99%)  1
Injury, poisoning and procedural complications   
Scar contracture release  [2]  1/101 (0.99%)  1
>10% graft loss  [1]  1/101 (0.99%)  1
Burn wound excision/grafting  [2]  1/101 (0.99%)  1
New burn injury  [1]  1/101 (0.99%)  1
New burn injury  [3]  1/101 (0.99%)  1
Graft failure conversion to full thickness wound  [1]  1/101 (0.99%)  1
Coumadin toxicity   1/101 (0.99%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism   1/101 (0.99%)  1
Vascular disorders   
Blood clot detected in left leg   1/101 (0.99%)  1
Indicates events were collected by systematic assessment
[1]
RECELL Recipient Site
[2]
Other wound
[3]
Control Recipient Site
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Experimental: All Participants (Within Patient Control)
Affected / at Risk (%) # Events
Total   34/101 (33.66%)    
General disorders   
Hypertrophy  [1]  7/101 (6.93%)  13
Skin and subcutaneous tissue disorders   
Hypertrophic Scar  [2]  15/101 (14.85%)  26
Rash  [3]  5/101 (4.95%)  6
Hypergranulated Tissue/Hypergranulation  [4]  7/101 (6.93%)  10
Itching/Pruritus  [5]  6/101 (5.94%)  14
Indicates events were collected by systematic assessment
[1]
RECELL Recipient Site (n=5) Control Recipient Site (n=3) Other (n=5)
[2]
RECELL Recipient Site (n=10) Control Recipient Site (n=6) Other (n=11)
[3]
RECELL Recipient Site (n=3) Control Recipient Site ((n=1) Other (n=2)
[4]
RECELL Recipient Site (n=8) Control Recipient Site (n=1) Other (n=1)
[5]
RECELL Recipient Site (n=5) Control Recipient site (n=5) Other (n=4)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Research
Organization: AVITA Medical
Phone: 661-367-9170
EMail: clinicaltrial@avitamedical.com
Layout table for additonal information
Responsible Party: Avita Medical
ClinicalTrials.gov Identifier: NCT01138917    
Other Study ID Numbers: CTP001-5
First Submitted: June 3, 2010
First Posted: June 8, 2010
Results First Submitted: October 9, 2018
Results First Posted: May 13, 2019
Last Update Posted: May 13, 2019