Trial Outcomes & Findings for StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects (NCT NCT00618839)
NCT ID: NCT00618839
Last Updated: 2019-10-16
Results Overview
The percentage take of the autografted area on each treatment site based on clinical judgement of visual and tactile assessments two weeks after autografting of wounds that had been temporarily covered with StrataGraft skin tissue.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
two weeks post-autografting
Results posted on
2019-10-16
Participant Flow
The study evaluated autograft take and infection in 15 patients with full-thickness skin defects who required sequential surgical procedures. Subjects had surgical excision and temporary placement of StrataGraft and cadaver allograft. The trial was conducted at the University of Wisconsin Hospital and the Arizona Burn Center.
All subjects were treated with both StrataGraft and cadaver allograft in a split-wound design. The half-wound sites were randomized to receive StrataGraft or cadaver allograft.
Participant milestones
| Measure |
StrataGraft : Cadaver Allograft
Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects
Baseline characteristics by cohort
| Measure |
StrataGraft : Cadaver Allograft
n=15 Participants
Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: two weeks post-autograftingPopulation: Intrapatient treatment sites were randomized such that each half of the wound site received StrataGraft and the other half received cadaver skin. Therefore, each patient received StrataGraft and cadaver allograft.
The percentage take of the autografted area on each treatment site based on clinical judgement of visual and tactile assessments two weeks after autografting of wounds that had been temporarily covered with StrataGraft skin tissue.
Outcome measures
| Measure |
StrataGraft Skin Tissue
n=15 Participants
StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
|
Cadaver Skin
n=15 Participants
The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by autografting once once sufficient donor skin is available for autografting. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
|
|---|---|---|
|
Percent Autograft Take on Wounds Prepared by StrataGraft™ Skin Tissue.
|
97.7 Percent Area of Autograft Take (%)
Standard Deviation 6.78
|
96.7 Percent Area of Autograft Take (%)
Standard Deviation 10.47
|
SECONDARY outcome
Timeframe: StrataGraft and cadaver allograft appearance were performed every other day after placement and at the time of allograft removal and the values averaged for each subject.Population: Treatment for each patient was randomized such that each half of the wound site received StrataGraft or cadaver skin. Therefore, each patient received StrataGraft and cadaver allograft.
The following three point scale was used to assess the condition of skin allografts: pink and adherent (2 points); either pink or adherent but not both (1 point); or neither pink nor adherent (0 points).
Outcome measures
| Measure |
StrataGraft Skin Tissue
n=15 Participants
StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
|
Cadaver Skin
n=15 Participants
The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by autografting once once sufficient donor skin is available for autografting. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
|
|---|---|---|
|
Appearance of Allograft Tissues
|
1.70 points
Standard Error 0.62
|
1.49 points
Standard Error 0.65
|
SECONDARY outcome
Timeframe: At the time of allograft removal (~7 days)Population: Treatment for each patient was randomized such that each half of the wound site received StrataGraft or cadaver skin. Therefore, each patient received StrataGraft and cadaver allograft.
Immunohistochemical staining for Ki67, a protein expressed only in proliferating cells.
Outcome measures
| Measure |
StrataGraft Skin Tissue
n=15 Participants
StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
|
Cadaver Skin
n=15 Participants
The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by autografting once once sufficient donor skin is available for autografting. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
|
|---|---|---|
|
Viability of Allograft Tissues
|
0.567 Ki67 positive cells/ total cells
Full Range 0.175 • Interval 0.283 to 0.807
|
0.189 Ki67 positive cells/ total cells
Full Range 0.315 • Interval 0.015 to 0.959
|
Adverse Events
StrataGraft : Cadaver Allograft
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
StrataGraft : Cadaver Allograft
n=15 participants at risk
Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
|
|---|---|
|
General disorders
IMPAIRED HEALING
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
6.7%
1/15 • Number of events 1
|
Other adverse events
| Measure |
StrataGraft : Cadaver Allograft
n=15 participants at risk
Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
|
|---|---|
|
Infections and infestations
INFECTION
|
60.0%
9/15 • Number of events 13
|
|
Gastrointestinal disorders
CONSTIPATION
|
53.3%
8/15 • Number of events 10
|
|
Gastrointestinal disorders
NAUSEA
|
53.3%
8/15 • Number of events 9
|
|
Psychiatric disorders
ANXIETY
|
40.0%
6/15 • Number of events 8
|
|
Gastrointestinal disorders
DIARRHOEA
|
46.7%
7/15 • Number of events 8
|
|
Psychiatric disorders
INSOMNIA
|
53.3%
8/15 • Number of events 8
|
|
Metabolism and nutrition disorders
ACIDOSIS
|
6.7%
1/15 • Number of events 1
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
6.7%
1/15 • Number of events 2
|
|
Psychiatric disorders
AGITATION
|
6.7%
1/15 • Number of events 1
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
13.3%
2/15 • Number of events 2
|
|
Investigations
ALBUMIN GLOBULIN RATIO DECREASED
|
6.7%
1/15 • Number of events 1
|
|
Blood and lymphatic system disorders
ANAEMIA
|
20.0%
3/15 • Number of events 3
|
|
Nervous system disorders
APHONIA
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.7%
1/15 • Number of events 1
|
|
Investigations
ASPARTATE AMINOTRANSFERASE DECREASED
|
6.7%
1/15 • Number of events 1
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
26.7%
4/15 • Number of events 4
|
|
General disorders
ASTHENIA
|
20.0%
3/15 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
13.3%
2/15 • Number of events 4
|
|
Investigations
BLOOD ALBUMIN DECREASED
|
20.0%
3/15 • Number of events 3
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
26.7%
4/15 • Number of events 4
|
|
Investigations
BLOOD BILIRUBIN DECREASED
|
20.0%
3/15 • Number of events 3
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
6.7%
1/15 • Number of events 1
|
|
Investigations
BLOOD CARBON DIOXIDE DECREASED
|
6.7%
1/15 • Number of events 1
|
|
Investigations
BLOOD CHLORIDE DECREASED
|
6.7%
1/15 • Number of events 1
|
|
Investigations
BLOOD CHLORIDE INCREASED
|
20.0%
3/15 • Number of events 3
|
|
Investigations
BLOOD CREATININE DECREASED
|
6.7%
1/15 • Number of events 1
|
|
Investigations
BLOOD CULTURE POSITIVE
|
20.0%
3/15 • Number of events 4
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
6.7%
1/15 • Number of events 1
|
|
Investigations
BLOOD MAGNESIUM INCREASED
|
26.7%
4/15 • Number of events 4
|
|
Investigations
BLOOD PHOSPHOROUS ELEVATED
|
6.7%
1/15 • Number of events 1
|
|
Investigations
BLOOD PHOSPHORUS INCREASED
|
6.7%
1/15 • Number of events 1
|
|
Investigations
BLOOD POTASSIUM DECREASED
|
6.7%
1/15 • Number of events 1
|
|
Investigations
BLOOD POTASSIUM INCREASED
|
6.7%
1/15 • Number of events 1
|
|
Investigations
BLOOD UREA DECREASED
|
20.0%
3/15 • Number of events 3
|
|
Investigations
BLOOD UREA INCREASED
|
13.3%
2/15 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
13.3%
2/15 • Number of events 3
|
|
Nervous system disorders
BURNING SENSATION
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
CELLULITIS
|
6.7%
1/15 • Number of events 1
|
|
General disorders
CHILLS
|
13.3%
2/15 • Number of events 3
|
|
Nervous system disorders
COGNITIVE DISORDER
|
6.7%
1/15 • Number of events 1
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
20.0%
3/15 • Number of events 4
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
6.7%
1/15 • Number of events 1
|
|
Investigations
CULTURE POSITIVE
|
6.7%
1/15 • Number of events 1
|
|
General disorders
CYST
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
6.7%
1/15 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCER
|
6.7%
1/15 • Number of events 1
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
6.7%
1/15 • Number of events 1
|
|
Psychiatric disorders
DEPRESSION
|
13.3%
2/15 • Number of events 2
|
|
Nervous system disorders
DIZZINESS
|
6.7%
1/15 • Number of events 1
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
6.7%
1/15 • Number of events 1
|
|
Renal and urinary disorders
DYSURIA
|
6.7%
1/15 • Number of events 1
|
|
Eye disorders
ECTROPION
|
6.7%
1/15 • Number of events 1
|
|
Investigations
ELEVATED PHOSPHOROUS
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
6.7%
1/15 • Number of events 1
|
|
Injury, poisoning and procedural complications
ESCHAR
|
13.3%
2/15 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
EXTRASKELETAL OSSIFICATION
|
6.7%
1/15 • Number of events 1
|
|
Eye disorders
EYE IRRITATION
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
FLATULENCE
|
6.7%
1/15 • Number of events 1
|
|
Investigations
GLOBULINS INCREASED
|
6.7%
1/15 • Number of events 1
|
|
Investigations
HAEMATOCRIT DECREASED
|
20.0%
3/15 • Number of events 3
|
|
Investigations
HAEMOGLOBIN DECREASED
|
13.3%
2/15 • Number of events 2
|
|
Infections and infestations
HERPES SIMPLEX
|
13.3%
2/15 • Number of events 2
|
|
Investigations
HIGH DENSITY LIPOPROTEIN DECREASED
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
HYPERAESTHESIA
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPERNATRAEMIA
|
6.7%
1/15 • Number of events 1
|
|
Vascular disorders
HYPERTENSION
|
26.7%
4/15 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
HYPERTROPHIC SCAR
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
HYPOAESTHESIA
|
13.3%
2/15 • Number of events 4
|
|
Gastrointestinal disorders
HYPOAESTHESIA ORAL
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
13.3%
2/15 • Number of events 2
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
33.3%
5/15 • Number of events 5
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
26.7%
4/15 • Number of events 5
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
6.7%
1/15 • Number of events 1
|
|
Vascular disorders
HYPOTENSION
|
6.7%
1/15 • Number of events 1
|
|
General disorders
HYPOTHERMIA
|
13.3%
2/15 • Number of events 2
|
|
General disorders
IMPAIRED HEALING
|
6.7%
1/15 • Number of events 2
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
20.0%
3/15 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
6.7%
1/15 • Number of events 1
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
LIMB DISCOMFORT
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
LIVEDO RETICULARIS
|
6.7%
1/15 • Number of events 1
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
13.3%
2/15 • Number of events 2
|
|
Investigations
MEAN PLATELET VOLUME DECREASED
|
26.7%
4/15 • Number of events 4
|
|
Congenital, familial and genetic disorders
MICROSTOMIA
|
6.7%
1/15 • Number of events 1
|
|
Investigations
MONOCYTE COUNT INCREASED
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
NEURALGIA
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
6.7%
1/15 • Number of events 1
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
13.3%
2/15 • Number of events 2
|
|
Renal and urinary disorders
NOCTURIA
|
6.7%
1/15 • Number of events 1
|
|
General disorders
OEDEMA
|
13.3%
2/15 • Number of events 2
|
|
General disorders
OEDEMA PERIPHERAL
|
13.3%
2/15 • Number of events 4
|
|
Injury, poisoning and procedural complications
OPEN WOUND
|
6.7%
1/15 • Number of events 1
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
PARAESTHESIA
|
13.3%
2/15 • Number of events 2
|
|
Investigations
PCO2 DECREASED
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
PERONEAL NERVE PALSY
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
13.3%
2/15 • Number of events 3
|
|
Investigations
PLATELET COUNT INCREASED
|
53.3%
8/15 • Number of events 8
|
|
Investigations
PLATELET MORPHOLOGY ABNORMAL
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
PNEUMONIA
|
33.3%
5/15 • Number of events 5
|
|
Vascular disorders
POOR PERIPHERAL CIRCULATION
|
6.7%
1/15 • Number of events 3
|
|
Investigations
PROTHROMBIN TIME PROLONGED
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
26.7%
4/15 • Number of events 5
|
|
Gastrointestinal disorders
PRURITUS ANI
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY CONGESTION
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
PURULENT DISCHARGE
|
6.7%
1/15 • Number of events 1
|
|
General disorders
PYREXIA
|
20.0%
3/15 • Number of events 5
|
|
Nervous system disorders
RADIAL NERVE PALSY
|
6.7%
1/15 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
RASH
|
26.7%
4/15 • Number of events 4
|
|
Investigations
RED BLOOD CELL COUNT DECREASED
|
13.3%
2/15 • Number of events 2
|
|
Investigations
RED BLOOD CELLS URINE
|
6.7%
1/15 • Number of events 1
|
|
Investigations
RED CELL DISTRIBUTION WIDTH INCREASED
|
13.3%
2/15 • Number of events 2
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
6.7%
1/15 • Number of events 1
|
|
Psychiatric disorders
RESTLESSNESS
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
SEPTIC SHOCK
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
SINUSITIS
|
13.3%
2/15 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
SOMNOLENCE
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
TACHYCARDIA
|
6.7%
1/15 • Number of events 1
|
|
General disorders
TENDERNESS
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
TOOTH DISORDER
|
6.7%
1/15 • Number of events 1
|
|
Investigations
TRANSFERRIN DECREASED
|
20.0%
3/15 • Number of events 3
|
|
Nervous system disorders
TREMOR
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
ULCER
|
6.7%
1/15 • Number of events 1
|
|
Renal and urinary disorders
URINARY RETENTION
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.7%
1/15 • Number of events 1
|
|
Investigations
URINE OUTPUT DECREASED
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
VENTRICULAR EXTRASYSTOLES
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
20.0%
3/15 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
6.7%
1/15 • Number of events 1
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
20.0%
3/15 • Number of events 3
|
|
Injury, poisoning and procedural complications
WOUND
|
6.7%
1/15 • Number of events 1
|
|
Surgical and medical procedures
WOUND CLOSURE
|
6.7%
1/15 • Number of events 1
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
WOUND INFECTION
|
13.3%
2/15 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place