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

• Sponsor: Avita Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02380612
• Collaborator: MedDRA Assistance Inc (Other), Advanced Clinical Research Services, LLC (Other)
• Enrollment: 30
• Locations: 7
• Arm: 1
• Actual Duration (Months): 24.2
• Patients Per Site: 4.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burns	Device: ReCell Treatment; Procedure: Skin Graft	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: The participant and blinded evaluator will be not be told which treatment area received which treatment (RECELL or Control).
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Jan 26, 2015
• Actual Primary Completion Date: Jan 21, 2016
• Actual Study Completion Date: Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All Participants (within patient control) 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	Device: ReCell Treatment; Procedure: Skin Graft

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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).

2. Patient's Satisfaction/Treatment Preference [At 24 Week]

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Burn Center at Maricopa Medical Center	Phoenix	Arizona	United States	85008
2	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
3	Tampa General Hospital	Tampa	Florida	United States	33606
4	North Carolina Jaycee Burn Center	Chapel Hill	North Carolina	United States	27599
5	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina	United States	27157
6	University of Tennessee Health Science Center	Memphis	Tennessee	United States	38103-3409
7	USAISR - US Army Institute of Surgical Research	Fort Sam Houston	Texas	United States	78234

Sponsors and Collaborators

• Avita Medical
• MedDRA Assistance Inc
• Advanced Clinical Research Services, LLC

Investigators

• Principal Investigator: James H Holmes, IV, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Avita Medical
• ClinicalTrials.gov Identifier: NCT02380612
• Other Study ID Numbers: CTP001-6
• First Posted: Mar 5, 2015
• Last Update Posted: Feb 23, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Avita Medical: Second Degree Burn Injuries
• Additional relevant MeSH terms: Burns

Study Results

Participant Flow

Arm/Group Title	Experimental: All Participants (Within Patient Control)
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

Baseline Characteristics

Arm/Group Title	Experimental: All Participants (Within Patient Control)
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 Participants	30
Age (Count of Participants)
<=18 years	3 10%
Between 18 and 65 years	25 83.3%
>=65 years	2 6.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.1 (15.84)
Sex: Female, Male (Count of Participants)
Female	25 83.3%
Male	5 16.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 3.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	6 20%
White	20 66.7%
More than one race	0 0%
Unknown or Not Reported	3 10%
Region of Enrollment (participants) [Number]
United States	30 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)
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

Outcome Measure Data

Analysis Population Description

Per Protocol Population

Arm/Group Title	RECELL-Treated	Control
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).
Measure Participants	26	26
Confirmed Closure	24 80%	22 NaN
Not Healed	2 6.7%	4 NaN

2. Primary Outcome

Title	Actual Expansion Ratios (Treatment Area to Donor Site Area, Inclusive of Donor Skin Needed for Secondary Treatments)
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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population (primary analysis)

Arm/Group Title	RECELL-Treated	Control
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).
Measure Participants	30	30
Geometric Mean (Standard Deviation) [cm2]	1.9657 (2.0415)	1.3486 (1.4143)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RECELL-Treated, Control
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	1.4575
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Observer Overall Patient and Observer Scar Assessment Scale ( POSAS) Opinion Score
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

Outcome Measure Data

Analysis Population Description

Per-Protocol Population

Arm/Group Title	RECELL-Treated	Control
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).
Measure Participants	26	26
Mean (Standard Deviation) [units on a scale]	2.6 (1.20)	2.5 (1.42)

4. Secondary Outcome

Title	Patient's Satisfaction/Treatment Preference
Time Frame	At 24 Week

Outcome Measure Data

Analysis Population Description

Per-Protocol Population

Arm/Group Title	All Subjects
Arm/Group Description	Every subject received both interventions (RECELL and CONTROL)
Measure Participants	26
Preferred RECELL	12 40%
Preferred CONTROL	12 40%
No Preference	2 6.7%

5. Secondary Outcome

Title	Patient Overall Patient and Observer Scar Assessment Scale (POSAS) Opinion Score
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

Outcome Measure Data

Analysis Population Description

Per-Protocol Population

Arm/Group Title	RECELL-Treated	CONTROL
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).
Measure Participants	25	25
Mean (Standard Deviation) [units on a scale]	5.2 (2.76)	5.1 (2.96)

Adverse Events

Time Frame	52 Weeks
Arm/Group Title	Experimental: All Participants (Within Patient Control)
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 (%)	# Events
Total	1/30 (3.3%)
Serious Adverse Events
	Experimental: All Participants (Within Patient Control)
	Affected / at Risk (%)	# Events
Total	12/30 (40%)
Gastrointestinal disorders
Nausea	1/30 (3.3%)	2
Vomiting	1/30 (3.3%)	2
Ileus	1/30 (3.3%)	1
General disorders
Patient Concern for Infection	1/30 (3.3%)	1
Infections and infestations
Cellulitis Left Index Finger	1/30 (3.3%)	1
Cellulitis to Non-Study Donor Site	1/30 (3.3%)	1
Injury, poisoning and procedural complications
Failed Skin Graft	1/30 (3.3%)	1
Graft Loss	1/30 (3.3%)	1
Re-grafting Due to Graft Failure	1/30 (3.3%)	1
Surgery for Failed Skin Graft	1/30 (3.3%)	1
Graft Loss to Left Lower Extremity (LLE)	1/30 (3.3%)	1
Re-Grafting Due to Graft Failure	1/30 (3.3%)	1
Open Wound Left Elbow	1/30 (3.3%)	1
Graft Loss	1/30 (3.3%)	1
Graft Shearing/Loss to Left Calf	1/30 (3.3%)	1
Musculoskeletal and connective tissue disorders
Severe Contracture left hand, left wrist, left fingers and left lower eyelid	1/30 (3.3%)	1
Increased Elbow Pain, Right	1/30 (3.3%)	1
Inability to Move Right Elbow	1/30 (3.3%)	1
Intractable Pain Right Arm	1/30 (3.3%)	1
Nervous system disorders
Right Frontotemporal Subarachnoid Hemorrhage	1/30 (3.3%)	1
Psychiatric disorders
Psychosis	1/30 (3.3%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema	1/30 (3.3%)	1
Acute respiratory distress syndrome (ARDS)	1/30 (3.3%)	1
Other (Not Including Serious) Adverse Events
	Experimental: All Participants (Within Patient Control)
	Affected / at Risk (%)	# Events
Total	26/30 (86.7%)
General disorders
Chronic Pain	1/30 (3.3%)	1
Delayed Healing	1/30 (3.3%)	1
Increased Pain	1/30 (3.3%)	1
Chronic Pain	1/30 (3.3%)	1
Delayed Healing	3/30 (10%)	3
White creamy exudates left lower leg	1/30 (3.3%)	1
Chronic pain	1/30 (3.3%)	1
Non-healing wound to posterior left upper arm	1/30 (3.3%)	1
Infections and infestations
Mildly Infected	1/30 (3.3%)	1
Infection of the L Lower Leg	1/30 (3.3%)	2
Left thigh donor site with purulent drainage and open areas	1/30 (3.3%)	1
Arm burn cellulitis	1/30 (3.3%)	1
Klebsiella Pneumonia	1/30 (3.3%)	1
Injury, poisoning and procedural complications
Shearing of Graft on Site A 0.9x1 cm	1/30 (3.3%)	1
Abrasion	1/30 (3.3%)	1
Scratch on Back	1/30 (3.3%)	1
Small area of graft loss on anterior right lower extremity	1/30 (3.3%)	1
Graft Loss Posterior Back	1/30 (3.3%)	1
Graft Loss	1/30 (3.3%)	1
Abrasion to shin	1/30 (3.3%)	1
Graft loss posterior back	1/30 (3.3%)	1
Abrasion to knee	1/30 (3.3%)	1
Scratch at the back	1/30 (3.3%)	1
Graft loss l breast	1/30 (3.3%)	1
Medial left upper arm graft loss	1/30 (3.3%)	1
Graft loss chest wall at inner axilla	1/30 (3.3%)	1
Musculoskeletal and connective tissue disorders
Pain/Soreness Under Right Arm	1/30 (3.3%)	1
Ossification	1/30 (3.3%)	1
Pain right hand	1/30 (3.3%)	1
Heterotrophic ossification	1/30 (3.3%)	1
Contracture, right hand	1/30 (3.3%)	1
Nervous system disorders
Neuropathic Pain	1/30 (3.3%)	1
Burning	1/30 (3.3%)	1
Neuropathic Pain	1/30 (3.3%)	1
Burning	1/30 (3.3%)	1
Neuropathic pain	1/30 (3.3%)	1
Burning	1/30 (3.3%)	1
Psychiatric disorders
Confusion	1/30 (3.3%)	1
Skin and subcutaneous tissue disorders
Itching	6/30 (20%)	6
Dermatitis	1/30 (3.3%)	1
Pruritis	1/30 (3.3%)	1
Rash	1/30 (3.3%)	1
Chronic non-healing wounds to RLE secondary to DM type 1	1/30 (3.3%)	1
Itching	6/30 (20%)	6
Dermatitis	1/30 (3.3%)	1
Pruritis	1/30 (3.3%)	1
Chronic non-healing wounds to LLE secondary to DM type 1	1/30 (3.3%)	1
Itching	2/30 (6.7%)	2
Pruritus	1/30 (3.3%)	1
Blisters	1/30 (3.3%)	1
Itching	4/30 (13.3%)	4
Dermatitis	1/30 (3.3%)	1
Pruritis	1/30 (3.3%)	1
Rash	1/30 (3.3%)	1
Blisters to left thigh non-study donor	1/30 (3.3%)	1
Blisters to right thigh non-study graft	1/30 (3.3%)	1
Contact dermatitis at neck and upper back	1/30 (3.3%)	1
Surgical and medical procedures
Scar Revision	1/30 (3.3%)	1
Scar Revision	1/30 (3.3%)	1
Scar revision	1/30 (3.3%)	1

Limitations/Caveats

[Not Specified]

More Information

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.