Study: NCT01437852

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Impaired healing
Serious: yes
Organ System: General disorders
Notes: AE considered possibly related to the StrataGraft skin tissue treatment due to inappropriate selection of full-thickness wound that did not meet study inclusion.
Frequency: 1 affected / 30 at risk

Adverse event: Pain
Serious: yes
Organ System: Nervous system disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Transplant failure
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 30 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Acute respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 30 at risk

Adverse event: Abscess, limb
Serious: no
Organ System: Infections and infestations
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 30 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 3 affected / 30 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 3 affected / 30 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse events (AE) were judged to be possibly related to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Cephalhaematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Coagulopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Corneal neovascularisation
Serious: no
Organ System: Eye disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Debridement
Serious: no
Organ System: Surgical and medical procedures
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 30 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Gout
Serious: no
Organ System: Immune system disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Graft complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 30 at risk

Adverse event: Graft infection
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Hyperaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Hypermetabolism
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 3 affected / 30 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 30 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 30 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Impaired healing
Serious: no
Organ System: General disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 30 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Functional gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Joint contracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 30 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Keratitis, fungal
Serious: no
Organ System: Infections and infestations
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 30 at risk

Adverse event: Muscule contracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 30 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 3 affected / 30 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 30 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 30 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Peroneal nerve palsy
Serious: no
Organ System: Nervous system disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Post procedural infection
Serious: no
Organ System: Infections and infestations
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Prostate infection
Serious: no
Organ System: Infections and infestations
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Three subjects adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. Two subjects AE were judged to be possibly related to treatment with StrataGraft skin tissue.
Frequency: 5 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Rash vesicular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse events (AE) were judged to be probably related to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Vancomycin infusion reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Renal failure, acute
Serious: no
Organ System: Renal and urinary disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Respiratory acidosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Sarcoidosis
Serious: no
Organ System: Immune system disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Sensory disturbance
Serious: no
Organ System: Nervous system disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Thrombophlebitis
Serious: no
Organ System: Vascular disorders
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Wisdom teeth removal
Serious: no
Organ System: Surgical and medical procedures
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Wound drainage
Serious: no
Organ System: Surgical and medical procedures
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Wound haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk

Adverse event: Wound infection, Staphylococcal
Serious: no
Organ System: Infections and infestations
Notes: All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 30 at risk