Study: NCT02380612

Adverse event: Failed Skin Graft
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 30 at risk

Adverse event: Graft loss
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 30 at risk

Adverse event: Re-grafting Due to Graft Failure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: CONTROL
Frequency: 1 affected / 30 at risk

Adverse event: Surgery for Failed Skin Graft
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: CONTROL
Frequency: 1 affected / 30 at risk

Adverse event: Graft Loss to Left Lower Extremity (LLE)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: CONTROL
Frequency: 1 affected / 30 at risk

Adverse event: Re-Grafting Due to Graft Failure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Severe Contracture left hand, left wrist, left fingers and left lower eyelid
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Open Wound Left Elbow
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Increased Elbow Pain, Right
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Inability to Move Right Elbow
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Intractable Pain Right Arm
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Cellulitis Left Index Finger
Serious: yes
Organ System: Infections and infestations
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Cellulitis to Non-Study Donor Site
Serious: yes
Organ System: Infections and infestations
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Graft loss
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Graft Shearing/Loss to Left Calf
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Patient Concern for Infection
Serious: yes
Organ System: General disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 30 at risk

Adverse event: Acute respiratory distress syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Right Frontotemporal Subarachnoid Hemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: RECELL
Frequency: 6 affected / 30 at risk

Adverse event: Pain/Soreness Under Right Arm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: RECELL
Frequency: 1 affected / 30 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: RECELL
Frequency: 1 affected / 30 at risk

Adverse event: Skin cosmetic procedure
Serious: no
Organ System: Surgical and medical procedures
Notes: RECELL
Frequency: 1 affected / 30 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Notes: RECELL
Frequency: 1 affected / 30 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: RECELL
Frequency: 1 affected / 30 at risk

Adverse event: Burning
Serious: no
Organ System: Nervous system disorders
Notes: RECELL
Frequency: 1 affected / 30 at risk

Adverse event: Shearing of Graft on Site A 0.9x1 cm
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 30 at risk

Adverse event: Delayed Healing
Serious: no
Organ System: General disorders
Notes: RECELL
Frequency: 1 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: RECELL
Frequency: 1 affected / 30 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: RECELL
Frequency: 1 affected / 30 at risk

Adverse event: Increased Pain
Serious: no
Organ System: General disorders
Notes: RECELL
Frequency: 1 affected / 30 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 30 at risk

Adverse event: Scratch on Back
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 30 at risk

Adverse event: Small area of graft loss on anterior right lower extremity
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 30 at risk

Adverse event: Chronic non-healing wounds to RLE secondary to DM type 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: RECELL
Frequency: 1 affected / 30 at risk

Adverse event: Graft Loss Posterior Back
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: CONTROL
Frequency: 6 affected / 30 at risk

Adverse event: Mildly Infected
Serious: no
Organ System: Infections and infestations
Notes: CONTROL
Frequency: 1 affected / 30 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: CONTROL
Frequency: 1 affected / 30 at risk

Adverse event: Skin cosmetic procedure
Serious: no
Organ System: Surgical and medical procedures
Notes: CONTROL
Frequency: 1 affected / 30 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Notes: CONTROL
Frequency: 1 affected / 30 at risk

Adverse event: Graft loss
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: CONTROL
Frequency: 1 affected / 30 at risk

Adverse event: Delayed Healing
Serious: no
Organ System: General disorders
Notes: CONTROL
Frequency: 3 affected / 30 at risk

Adverse event: Ossification
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: CONTROL
Frequency: 1 affected / 30 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: CONTROL
Frequency: 1 affected / 30 at risk

Adverse event: Burning
Serious: no
Organ System: Nervous system disorders
Notes: CONTROL
Frequency: 1 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: CONTROL
Frequency: 1 affected / 30 at risk

Adverse event: Abrasion to shin
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: CONTROL
Frequency: 1 affected / 30 at risk

Adverse event: White creamy exudates left lower leg
Serious: no
Organ System: General disorders
Notes: CONTROL
Frequency: 1 affected / 30 at risk

Adverse event: Infection of the L Lower Leg
Serious: no
Organ System: Infections and infestations
Notes: CONTROL
Frequency: 1 affected / 30 at risk

Adverse event: Chronic non-healing wounds to LLE secondary to DM type 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: CONTROL
Frequency: 1 affected / 30 at risk

Adverse event: Graft loss posterior back
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: CONTROL
Frequency: 1 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: DONOR SITE
Frequency: 2 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: DONOR SITE
Frequency: 1 affected / 30 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: DONOR SITE
Frequency: 1 affected / 30 at risk

Adverse event: Left thigh donor site with purulent drainage and open areas
Serious: no
Organ System: Infections and infestations
Notes: DONOR SITE
Frequency: 1 affected / 30 at risk

Adverse event: Pain right hand
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: NON-STUDY AREA
Frequency: 4 affected / 30 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Skin cosmetic procedure
Serious: no
Organ System: Surgical and medical procedures
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Heterotrophic ossification
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Burning
Serious: no
Organ System: Nervous system disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Contracture, right hand
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Blisters to left thigh non-study donor
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Blisters to right thigh non-study graft
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Non-healing wound to posterior left upper arm
Serious: no
Organ System: General disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Abrasion to knee
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Scratch at the back
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Contact dermatitis at neck and upper back
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Graft loss l breast
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Medial left upper arm graft loss
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Arm burn cellulitis
Serious: no
Organ System: Infections and infestations
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Graft loss chest wall at inner axilla
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: NON-STUDY AREA
Frequency: 1 affected / 30 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pneumonia klebsiella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk