Trial Outcomes & Findings for Continued Access to the Recell® Device for Treatment of Acute Burn Injuries (NCT NCT03333941)
NCT ID: NCT03333941
Last Updated: 2024-07-30
Results Overview
Treatment area will be evaluated via direct visualization by the treating investigator. Complete wound closure is defined as ≥95 to100% re-epithelialization without drainage by week 8.
Recruitment status
COMPLETED
Target enrollment
76 participants
Primary outcome timeframe
Confirmed by week 8, at two consecutive study visits at least 2 weeks apart up to 24 Weeks (e.g., at week 4 and week 8, or if a visit was missed, week 4 and week 12)
Results posted on
2024-07-30
Participant Flow
Participant milestones
| Measure |
RES (Regenerative Epithelial Suspension)
ReCell® Autologous Cell Harvesting Device: RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting.
|
|---|---|
|
Overall Study
STARTED
|
76
|
|
Overall Study
COMPLETED
|
63
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
RES (Regenerative Epithelial Suspension)
ReCell® Autologous Cell Harvesting Device: RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
|
Overall Study
Death
|
2
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Continued Access to the Recell® Device for Treatment of Acute Burn Injuries
Baseline characteristics by cohort
| Measure |
RES (Regenerative Epithelial Suspension)
n=76 Participants
ReCell® Autologous Cell Harvesting Device: RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting.
|
|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 20.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Confirmed by week 8, at two consecutive study visits at least 2 weeks apart up to 24 Weeks (e.g., at week 4 and week 8, or if a visit was missed, week 4 and week 12)Population: Per Protocol
Treatment area will be evaluated via direct visualization by the treating investigator. Complete wound closure is defined as ≥95 to100% re-epithelialization without drainage by week 8.
Outcome measures
| Measure |
RES (Regenerative Epithelial Suspension)
n=76 Participants
ReCell® Autologous Cell Harvesting Device: RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting.
|
|---|---|
|
Percentage of Participants With Wound Healing
|
95.3 percentage of participants
|
Adverse Events
RES (Regenerative Epithelial Suspension)
Serious events: 16 serious events
Other events: 39 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
RES (Regenerative Epithelial Suspension)
n=76 participants at risk
ReCell® Autologous Cell Harvesting Device: RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting.
|
|---|---|
|
Injury, poisoning and procedural complications
Non-healing Third Degree Burn R/T Caffeine Intake Capillary Constriction LL Arm Req. Add'l Grafting
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Pseudomonas Infection of Grafts
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Graft Loss Due to Immobility Over Posteriorly Located Pressure Bearing Surfaces Requiring Re-graftin
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Wound Cultures Positive for Staph Aureus Requiring Surgical Intervention
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Area of Flap Dehisced Requiring Inset of Flap Under Anesthesia
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Inpatient Surgery for Excision and Scar Release
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Graft Loss with Wound Infection
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Wound Infection Pseudomonas Aeruginosa
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Graft Failure with Wound Infection
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
100% Graft Loss Right Leg
|
1.3%
1/76 • Number of events 2 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Gastrointestinal disorders
Colonic Perforation and Evisceration
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Cardiac disorders
Aortic Thrombus
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Stage 3 Necrotic Pressure Ulcer Right Heel
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Ecoli Bacteremia
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Renal and urinary disorders
Multi-Organ Dysfunction with Acute Kidney Injury
|
1.3%
1/76 • 24 Weeks
|
|
Cardiac disorders
Cardiac Arrest with Return of Spontaneous Circulation
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure with Hypercapnia
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Blood and lymphatic system disorders
Acute Blood Loss Anemia Secondary to Epistaxis, Gastric Bleeding Evidenced by Wheezing & Edema
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Sepsis
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Blood and lymphatic system disorders
Acute Blood Loss Anemia
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulselessness Due to Progression of Metastatic State 4 Lung Cancer
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Cardiac disorders
Myocardial Infarction
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Ventilator Associated Pneumonia-Pseudomonas
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Septic Shock
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Cardiac disorders
Symptomatic Bradycardia
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Blood and lymphatic system disorders
Worsening Hyperglycemia
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Ventilator Associated Pneumonia
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Sepsis - Wound Infection
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Cardiac disorders
Cardiac Arrest
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Blood and lymphatic system disorders
Hospitalized for Hyperglycemia
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Death due to Drug Overdose
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
Other adverse events
| Measure |
RES (Regenerative Epithelial Suspension)
n=76 participants at risk
ReCell® Autologous Cell Harvesting Device: RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting.
|
|---|---|
|
Vascular disorders
Ulnar Neuropathy of Left Upper Extremity
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Vascular disorders
Worsening of Previous Medical History of Neuropathic Pain
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Increase in Past Medical History of Acute Pain due to Burn Injury
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Melting Graft Wound Syndrome
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Slowly Healing Donor Sites at Distal Bilateral Lower Extremities Requring Excision
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Graft Melt Bilateral Posterior Lower Extremities
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
General disorders
Fall with Body Laceration of Study Treatment Area
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Burn Injury Resulted in Exposure of Implantable Defribrillator
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Graft Failure 275 sq cm
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Graft Failure Approximately 275 Sq Cm.
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Bleeding to Surgical Site
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Graft Failure 150 sq cm
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Necrosis Left Knee
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Graft Failure 9 sq cm due to Knee Immobilizer
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Failed Graft Requiring Surgery
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Hypergranulation Tissue Left Torso
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Vascular disorders
Bleeding
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Hypergranulation Tissue
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Eschar Left Elbow
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Hypergranulation Tissue Knees and Calf
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Hypergranulation Tissue Feet
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Infection
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Graft Loss Right Breast
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Graft Loss to Right Thigh
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Graft Loss Abdomen
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Graft Loss Left Breast
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Graft Loss (R Buttock)
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Suspected Wound Infection (Right Buttock)
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Hypertrophic Scar to Back of Right Knee
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
General disorders
Burn Site Pain
|
5.3%
4/76 • Number of events 4 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Itching
|
2.6%
2/76 • Number of events 2 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Burn Itching
|
2.6%
2/76 • Number of events 2 • 24 Weeks
|
|
Blood and lymphatic system disorders
Blood Loss Anemia
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Decreased Range of Motion of Bilateral Lower Extremities and Hands
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Postoperative Pain
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Crusting Wounds at Right Ear, Scalp and Forehead
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Psychiatric disorders
Increased Delirium
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia (Increased from Prior Medical History)
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Eye disorders
Growth in Right Eyelid (Unknown Type)
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Eye disorders
Right Eye Ectropian
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Graft Loss Right Forearm
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Graft Loss (L Buttock)
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Suspected Wound Infection (Left Buttock)
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Hypertrophic Scarring of Left Buttock
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Gastrointestinal disorders
Indigestion
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Psychiatric disorders
Anxiety
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Psychiatric disorders
Insomnia
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Metabolism and nutrition disorders
Fluid Overload
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
General disorders
Bilateral Lower Extremity Edema
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Acute Blood Loss Due to Postoperative Anemia
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Vascular disorders
Hypotensive Episode
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.6%
2/76 • Number of events 2 • 24 Weeks
|
|
Investigations
Low Arterial Blood Pressure Postoperatively
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Blood and lymphatic system disorders
Anemia
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Bacteremia Secondary to Exposed ICD Generator
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Sepsis
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Urinary Tract Infection
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Klebsiella Pneumonia
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Suspected Urinary Tract Infection
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
MRSA Tracheobronchitis
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
General disorders
Fever
|
2.6%
2/76 • Number of events 2 • 24 Weeks
|
|
Gastrointestinal disorders
Gas
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Gastrointestinal disorders
Acid Reflux
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.3%
1/76 • Number of events 1 • 24 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place