Trial Outcomes & Findings for ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries (NCT NCT02380612)
NCT ID: NCT02380612
Last Updated: 2025-01-07
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
NA
Target enrollment
30 participants
Primary outcome timeframe
Prior to or at 8 weeks
Results posted on
2025-01-07
Participant Flow
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 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).
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries
Baseline characteristics by cohort
| Measure |
Experimental: All Participants (Within Patient Control)
n=30 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).
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|---|---|
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Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 15.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Prior to or at 8 weeksPopulation: Per Protocol Population
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.
Outcome measures
| Measure |
RECELL-Treated
n=26 Participants
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).
|
Control
n=26 Participants
Wound received an autograft consistent with the investigator's pre-identified graft plan (Control).
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|---|---|---|
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Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)
Confirmed Closure
|
24 Participants
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22 Participants
|
|
Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)
Not Healed
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Prior to or at 8 weeksPopulation: Intent-to-Treat Population (primary analysis)
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
| Measure |
RECELL-Treated
n=30 Participants
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).
|
Control
n=30 Participants
Wound received an autograft consistent with the investigator's pre-identified graft plan (Control).
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|---|---|---|
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Actual Expansion Ratios (Treatment Area to Donor Site Area, Inclusive of Donor Skin Needed for Secondary Treatments)
|
1.9657 cm2
Standard Deviation 2.0415
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1.3486 cm2
Standard Deviation 1.4143
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SECONDARY outcome
Timeframe: At 24 WeekPopulation: Per-Protocol Population
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).
Outcome measures
| Measure |
RECELL-Treated
n=26 Participants
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).
|
Control
n=26 Participants
Wound received an autograft consistent with the investigator's pre-identified graft plan (Control).
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|---|---|---|
|
Observer Overall Patient and Observer Scar Assessment Scale ( POSAS) Opinion Score
|
2.6 units on a scale
Standard Deviation 1.20
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2.5 units on a scale
Standard Deviation 1.42
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SECONDARY outcome
Timeframe: At 24 WeekPopulation: Per-Protocol Population
Outcome measures
| Measure |
RECELL-Treated
n=26 Participants
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).
|
Control
Wound received an autograft consistent with the investigator's pre-identified graft plan (Control).
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|---|---|---|
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Patient's Satisfaction/Treatment Preference
Preferred RECELL
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12 Participants
|
—
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Patient's Satisfaction/Treatment Preference
Preferred CONTROL
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12 Participants
|
—
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Patient's Satisfaction/Treatment Preference
No Preference
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2 Participants
|
—
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SECONDARY outcome
Timeframe: Week 24Population: Per-Protocol Population
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
Outcome measures
| Measure |
RECELL-Treated
n=25 Participants
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).
|
Control
n=25 Participants
Wound received an autograft consistent with the investigator's pre-identified graft plan (Control).
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|---|---|---|
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Patient Overall Patient and Observer Scar Assessment Scale (POSAS) Opinion Score
|
5.2 units on a scale
Standard Deviation 2.76
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5.1 units on a scale
Standard Deviation 2.96
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Adverse Events
Experimental: All Participants (Within Patient Control)
Serious events: 12 serious events
Other events: 26 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Experimental: All Participants (Within Patient Control)
n=30 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).
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|---|---|
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Injury, poisoning and procedural complications
Failed Skin Graft
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Graft Loss
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
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Injury, poisoning and procedural complications
Re-grafting Due to Graft Failure
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
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Injury, poisoning and procedural complications
Surgery for Failed Skin Graft
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
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Injury, poisoning and procedural complications
Graft Loss to Left Lower Extremity (LLE)
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
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Injury, poisoning and procedural complications
Re-Grafting Due to Graft Failure
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
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Musculoskeletal and connective tissue disorders
Severe Contracture left hand, left wrist, left fingers and left lower eyelid
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
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Injury, poisoning and procedural complications
Open Wound Left Elbow
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
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Musculoskeletal and connective tissue disorders
Increased Elbow Pain, Right
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Inability to Move Right Elbow
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Intractable Pain Right Arm
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Infections and infestations
Cellulitis Left Index Finger
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Infections and infestations
Cellulitis to Non-Study Donor Site
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Graft Shearing/Loss to Left Calf
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
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General disorders
Patient Concern for Infection
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
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Gastrointestinal disorders
Nausea
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3.3%
1/30 • Number of events 2 • 52 Weeks
|
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Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Number of events 2 • 52 Weeks
|
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Gastrointestinal disorders
Ileus
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
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Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
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Psychiatric disorders
Psychosis
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
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Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome (ARDS)
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Nervous system disorders
Right Frontotemporal Subarachnoid Hemorrhage
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
Other adverse events
| Measure |
Experimental: All Participants (Within Patient Control)
n=30 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).
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|---|---|
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Skin and subcutaneous tissue disorders
Itching
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13.3%
4/30 • Number of events 4 • 52 Weeks
|
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Musculoskeletal and connective tissue disorders
Pain/Soreness Under Right Arm
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
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General disorders
Chronic Pain
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
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Surgical and medical procedures
Scar Revision
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Nervous system disorders
Neuropathic Pain
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
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Nervous system disorders
Burning
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
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Injury, poisoning and procedural complications
Shearing of Graft on Site A 0.9x1 cm
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
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General disorders
Delayed Healing
|
10.0%
3/30 • Number of events 3 • 52 Weeks
|
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Skin and subcutaneous tissue disorders
Pruritis
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
General disorders
Increased Pain
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
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Injury, poisoning and procedural complications
Abrasion
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Scratch on Back
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
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Injury, poisoning and procedural complications
Small area of graft loss on anterior right lower extremity
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
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Skin and subcutaneous tissue disorders
Chronic non-healing wounds to RLE secondary to DM type 1
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Graft Loss Posterior Back
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3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Infections and infestations
Mildly Infected
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Graft Loss
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
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Musculoskeletal and connective tissue disorders
Ossification
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
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Injury, poisoning and procedural complications
Abrasion to shin
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
General disorders
White creamy exudates left lower leg
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Infections and infestations
Infection of the L Lower Leg
|
3.3%
1/30 • Number of events 2 • 52 Weeks
|
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Skin and subcutaneous tissue disorders
Chronic non-healing wounds to LLE secondary to DM type 1
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Graft loss posterior back
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Skin and subcutaneous tissue disorders
Blisters
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Infections and infestations
Left thigh donor site with purulent drainage and open areas
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Pain right hand
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
General disorders
Chronic pain
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Surgical and medical procedures
Scar revision
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Nervous system disorders
Neuropathic pain
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Heterotrophic ossification
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Contracture, right hand
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Skin and subcutaneous tissue disorders
Blisters to left thigh non-study donor
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Skin and subcutaneous tissue disorders
Blisters to right thigh non-study graft
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
General disorders
Non-healing wound to posterior left upper arm
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Abrasion to knee
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Scratch at the back
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis at neck and upper back
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Graft loss l breast
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Medial left upper arm graft loss
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Infections and infestations
Arm burn cellulitis
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Graft loss chest wall at inner axilla
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Psychiatric disorders
Confusion
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
|
Infections and infestations
Klebsiella Pneumonia
|
3.3%
1/30 • Number of events 1 • 52 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place