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ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries

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ClinicalTrials.gov Identifier: NCT02380612
Recruitment Status : Completed
First Posted : March 5, 2015
Results First Posted : February 23, 2021
Last Update Posted : February 23, 2021
Sponsor:
Collaborators:
MedDRA Assistance Inc
Advanced Clinical Research Services, LLC
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
Interventions Device: ReCell Treatment
Procedure: Skin Graft
Enrollment 30
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) 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 thee 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).
Period Title: Overall Study
Started 30
Completed 27
Not Completed 3
Arm/Group Title Experimental: All Participants (Within Patient Control)
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
3
  10.0%
Between 18 and 65 years
25
  83.3%
>=65 years
2
   6.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
39.1  (15.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
25
  83.3%
Male
5
  16.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  20.0%
White
20
  66.7%
More than one race
0
   0.0%
Unknown or Not Reported
3
  10.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title RECELL-Treated Control
Hide Arm/Group Description:
Wound received 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).
Wound received an autograft consistent with the investigator's pre-identified graft plan (Control).
Overall Number of Participants Analyzed 26 26
Measure Type: Count of Participants
Unit of Measure: Participants
Confirmed Closure
24
  92.3%
22
  84.6%
Not Healed
2
   7.7%
4
  15.4%
2.Primary Outcome
Title Actual Expansion Ratios (Treatment Area to Donor Site Area, Inclusive of Donor Skin Needed for Secondary Treatments)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population (primary analysis)
Arm/Group Title RECELL-Treated Control
Hide Arm/Group Description:
Wound received 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).
Wound received an autograft consistent with the investigator's pre-identified graft plan (Control).
Overall Number of Participants Analyzed 30 30
Geometric Mean (Standard Deviation)
Unit of Measure: cm2
1.9657  (2.0415) 1.3486  (1.4143)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RECELL-Treated, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.4575
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Observer Overall Patient and Observer Scar Assessment Scale ( POSAS) Opinion Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population
Arm/Group Title RECELL-Treated Control
Hide Arm/Group Description:
Wound received 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).
Wound received an autograft consistent with the investigator's pre-identified graft plan (Control).
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.6  (1.20) 2.5  (1.42)
4.Secondary Outcome
Title Patient's Satisfaction/Treatment Preference
Hide Description [Not Specified]
Time Frame At 24 Week
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population
Arm/Group Title All Subjects
Hide Arm/Group Description:
Every subject received both interventions (RECELL and CONTROL)
Overall Number of Participants Analyzed 26
Measure Type: Count of Participants
Unit of Measure: Participants
Preferred RECELL
12
  46.2%
Preferred CONTROL
12
  46.2%
No Preference
2
   7.7%
5.Secondary Outcome
Title Patient Overall Patient and Observer Scar Assessment Scale (POSAS) Opinion Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population
Arm/Group Title RECELL-Treated CONTROL
Hide Arm/Group Description:
Wound received 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).
Wound received an autograft consistent with the investigator's pre-identified graft plan (Control).
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.2  (2.76) 5.1  (2.96)
Time Frame 52 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental: All Participants (Within Patient Control)
Hide Arm/Group Description 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).
All-Cause Mortality
Experimental: All Participants (Within Patient Control)
Affected / at Risk (%)
Total   1/30 (3.33%)    
Hide Serious Adverse Events
Experimental: All Participants (Within Patient Control)
Affected / at Risk (%) # Events
Total   12/30 (40.00%)    
Gastrointestinal disorders   
Nausea   1/30 (3.33%)  2
Vomiting   1/30 (3.33%)  2
Ileus   1/30 (3.33%)  1
General disorders   
Patient Concern for Infection  [1]  1/30 (3.33%)  1
Infections and infestations   
Cellulitis Left Index Finger  [1]  1/30 (3.33%)  1
Cellulitis to Non-Study Donor Site  [1]  1/30 (3.33%)  1
Injury, poisoning and procedural complications   
Failed Skin Graft  [2]  1/30 (3.33%)  1
Graft Loss  [2]  1/30 (3.33%)  1
Re-grafting Due to Graft Failure  [3]  1/30 (3.33%)  1
Surgery for Failed Skin Graft  [3]  1/30 (3.33%)  1
Graft Loss to Left Lower Extremity (LLE)  [3]  1/30 (3.33%)  1
Re-Grafting Due to Graft Failure  [1]  1/30 (3.33%)  1
Open Wound Left Elbow  [1]  1/30 (3.33%)  1
Graft Loss  [1]  1/30 (3.33%)  1
Graft Shearing/Loss to Left Calf  [1]  1/30 (3.33%)  1
Musculoskeletal and connective tissue disorders   
Severe Contracture left hand, left wrist, left fingers and left lower eyelid  [1]  1/30 (3.33%)  1
Increased Elbow Pain, Right  [1]  1/30 (3.33%)  1
Inability to Move Right Elbow  [1]  1/30 (3.33%)  1
Intractable Pain Right Arm  [1]  1/30 (3.33%)  1
Nervous system disorders   
Right Frontotemporal Subarachnoid Hemorrhage   1/30 (3.33%)  1
Psychiatric disorders   
Psychosis   1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary Edema   1/30 (3.33%)  1
Acute respiratory distress syndrome (ARDS)   1/30 (3.33%)  1
Indicates events were collected by systematic assessment
[1]
NON-STUDY AREA
[2]
RECELL
[3]
CONTROL
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental: All Participants (Within Patient Control)
Affected / at Risk (%) # Events
Total   26/30 (86.67%)    
General disorders   
Chronic Pain  [1]  1/30 (3.33%)  1
Delayed Healing  [1]  1/30 (3.33%)  1
Increased Pain  [1]  1/30 (3.33%)  1
Chronic Pain  [2]  1/30 (3.33%)  1
Delayed Healing  [2]  3/30 (10.00%)  3
White creamy exudates left lower leg  [2]  1/30 (3.33%)  1
Chronic pain  [3]  1/30 (3.33%)  1
Non-healing wound to posterior left upper arm  [3]  1/30 (3.33%)  1
Infections and infestations   
Mildly Infected  [2]  1/30 (3.33%)  1
Infection of the L Lower Leg  [2]  1/30 (3.33%)  2
Left thigh donor site with purulent drainage and open areas  [4]  1/30 (3.33%)  1
Arm burn cellulitis  [3]  1/30 (3.33%)  1
Klebsiella Pneumonia   1/30 (3.33%)  1
Injury, poisoning and procedural complications   
Shearing of Graft on Site A 0.9x1 cm  [1]  1/30 (3.33%)  1
Abrasion  [1]  1/30 (3.33%)  1
Scratch on Back  [1]  1/30 (3.33%)  1
Small area of graft loss on anterior right lower extremity  [1]  1/30 (3.33%)  1
Graft Loss Posterior Back  [1]  1/30 (3.33%)  1
Graft Loss  [2]  1/30 (3.33%)  1
Abrasion to shin  [2]  1/30 (3.33%)  1
Graft loss posterior back  [2]  1/30 (3.33%)  1
Abrasion to knee  [3]  1/30 (3.33%)  1
Scratch at the back  [3]  1/30 (3.33%)  1
Graft loss l breast  [3]  1/30 (3.33%)  1
Medial left upper arm graft loss  [3]  1/30 (3.33%)  1
Graft loss chest wall at inner axilla  [3]  1/30 (3.33%)  1
Musculoskeletal and connective tissue disorders   
Pain/Soreness Under Right Arm  [1]  1/30 (3.33%)  1
Ossification  [2]  1/30 (3.33%)  1
Pain right hand  [3]  1/30 (3.33%)  1
Heterotrophic ossification  [3]  1/30 (3.33%)  1
Contracture, right hand  [3]  1/30 (3.33%)  1
Nervous system disorders   
Neuropathic Pain  [1]  1/30 (3.33%)  1
Burning  [1]  1/30 (3.33%)  1
Neuropathic Pain  [2]  1/30 (3.33%)  1
Burning  [2]  1/30 (3.33%)  1
Neuropathic pain  [3]  1/30 (3.33%)  1
Burning  [3]  1/30 (3.33%)  1
Psychiatric disorders   
Confusion   1/30 (3.33%)  1
Skin and subcutaneous tissue disorders   
Itching  [1]  6/30 (20.00%)  6
Dermatitis  [1]  1/30 (3.33%)  1
Pruritis  [1]  1/30 (3.33%)  1
Rash  [1]  1/30 (3.33%)  1
Chronic non-healing wounds to RLE secondary to DM type 1  [1]  1/30 (3.33%)  1
Itching  [2]  6/30 (20.00%)  6
Dermatitis  [2]  1/30 (3.33%)  1
Pruritis  [2]  1/30 (3.33%)  1
Chronic non-healing wounds to LLE secondary to DM type 1  [2]  1/30 (3.33%)  1
Itching  [4]  2/30 (6.67%)  2
Pruritus  [4]  1/30 (3.33%)  1
Blisters  [4]  1/30 (3.33%)  1
Itching  [3]  4/30 (13.33%)  4
Dermatitis  [3]  1/30 (3.33%)  1
Pruritis  [3]  1/30 (3.33%)  1
Rash  [3]  1/30 (3.33%)  1
Blisters to left thigh non-study donor  [3]  1/30 (3.33%)  1
Blisters to right thigh non-study graft  [3]  1/30 (3.33%)  1
Contact dermatitis at neck and upper back  [3]  1/30 (3.33%)  1
Surgical and medical procedures   
Scar Revision  [1]  1/30 (3.33%)  1
Scar Revision  [2]  1/30 (3.33%)  1
Scar revision  [3]  1/30 (3.33%)  1
Indicates events were collected by systematic assessment
[1]
RECELL
[2]
CONTROL
[3]
NON-STUDY AREA
[4]
DONOR SITE
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: VP 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: NCT02380612    
Other Study ID Numbers: CTP001-6
First Submitted: February 17, 2015
First Posted: March 5, 2015
Results First Submitted: September 25, 2018
Results First Posted: February 23, 2021
Last Update Posted: February 23, 2021