Assessment of Safety and Effectiveness of Biodegradable T... | NCT02905435

Name	Class
PPD Development, LP	INDUSTRY
Department of Health and Human Services	FED
Biomedical Advanced Research and Development Authority	FED

Label	Type	Description	Intervention Names
Biodegradable Temporizing Matrix	Experimental	Biodegradable Temporizing Matrix (BTM)	Device: Biodegradable Temporizing Matrix

Name	Type	Description	Arm Group Labels	Other Names
Biodegradable Temporizing Matrix	Device	The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Measure	Description	Time Frame
BTM 'Take' Rate	Percentage of total body surface area (%TBSA) of BTM that has adhered at time of skin grafting, divided by the %TBSA treated with BTM, then multiplied by 100 to express as a percentage. Calculated per study lesion and averaged per participant.	At time of application of split skin graft (SSG) (typically 28-35 days after application of BTM, Day 0)
SSG 'Take' Rate Over BTM	The amount (calculated as a percentage) of split skin graft (SSG) that 'takes' expressed as a proportion of SSG applied at 7-10 days after application of SSG. Calculated per study lesion and averaged for each participant.	7-10 days after application of SSG
Adverse Events	Number and type of Adverse Events occurring after BTM implantation	All timepoints until 12 months after application of SSG

Measure	Description	Time Frame
Infection	Incidence of infections in BTM-treated areas, and the success of treatment of local infections with BTM in place. Results will be combined and expressed as local infection rate and response rate to treatment.	From day of application (Day 0) until 12 months after SSG.
Wound Closure - Anterior Torso

Name	Affiliation	Role
Marcus JD Wagstaff, MBBS, PhD	Royal Adelaide Hospital, Adelaide SA 5000, AUSTRALIA	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Burn Center at Maricopa Medical Center		Phoenix	Arizona	85008	United States
University of California Davis Medical Center

Label	URL
Sponsor website	View source

ID	Title	Description
FG000	Biodegradable Temporizing Matrix	Biodegradable Temporizing Matrix (BTM) Biodegradable Temporizing Matrix: The Biodegradable Temporizing Matrix (BTM) (also known as BTM Dressing) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 19, 2017	Apr 19, 2021

ID	Title	Description
BG000	Biodegradable Temporizing Matrix	Biodegradable Temporizing Matrix (BTM) Biodegradable Temporizing Matrix: The Biodegradable Temporizing Matrix (BTM) (also known as BTM Dressing) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Units	Counts
Participants	BG00014

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

BTM 'Take' Rate

Percentage of total body surface area (%TBSA) of BTM that has adhered at time of skin grafting, divided by the %TBSA treated with BTM, then multiplied by 100 to express as a percentage. Calculated per study lesion and averaged per participant.

Intention to treat

Posted

Mean

Standard Deviation

percentage of BTM take per subject

At time of application of split skin graft (SSG) (typically 28-35 days after application of BTM, Day 0)

ID	Title	Description
OG000	Biodegradable Temporizing Matrix (BTM)	The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Units	Counts
Participants	OG00012

Title

Denominators

Categories

Title	Measurements
	OG00095.22± 7.175

Primary

SSG 'Take' Rate Over BTM

The amount (calculated as a percentage) of split skin graft (SSG) that 'takes' expressed as a proportion of SSG applied at 7-10 days after application of SSG. Calculated per study lesion and averaged for each participant.

Intention to treat

Posted

Mean

Standard Deviation

percentage of SSG take per subject

7-10 days after application of SSG

ID	Title	Description
OG000	Biodegradable Temporizing Matrix (BTM)	The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Units	Counts
Participants	OG000

Primary

Adverse Events

Number and type of Adverse Events occurring after BTM implantation

Intention to treat

Posted

Number

adverse events

All timepoints until 12 months after application of SSG

ID	Title	Description
OG000	Biodegradable Temporizing Matrix (BTM)	The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Units	Counts
Participants	OG000

Secondary

Infection

Incidence of infections in BTM-treated areas, and the success of treatment of local infections with BTM in place. Results will be combined and expressed as local infection rate and response rate to treatment.

Posted

Count of Units

Wounds treated with BTM

From day of application (Day 0) until 12 months after SSG.

Wounds treated with BTM

ID	Title	Description
OG000	Biodegradable Temporizing Matrix (BTM)	The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Units	Counts
Participants	OG000

Secondary

Wound Closure - Anterior Torso

Clinical assessment of wound closure expressed as a percentage, per anatomical region

Intention to treat

Posted

Mean

Standard Deviation

% wound closure

1, 2, 3, 6, 12 months after application of SSG

Wounds treated with BTM

ID	Title	Description
OG000	Biodegradable Temporizing Matrix (BTM)	The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Units	Counts
Participants	OG000

Secondary

Wound Closure - Left Lower Limb

Clinical assessment of wound closure expressed as a percentage, per anatomical region

Intention to treat

Posted

Mean

Standard Deviation

% wound closure

1, 2, 3, 6, 12 months after application of SSG

Wounds treated with BTM

ID	Title	Description
OG000	Biodegradable Temporizing Matrix (BTM)	The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Units	Counts
Participants	OG000

Secondary

Wound Closure - Left Upper Limb

Clinical assessment of wound closure expressed as a percentage, per anatomical region

Intention to treat

Posted

Mean

Standard Deviation

% wound closure

1, 2, 3, 6, 12 months after application of SSG

Wounds treated with BTM

ID	Title	Description
OG000	Biodegradable Temporizing Matrix (BTM)	The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Units	Counts
Participants	OG000

Secondary

Wound Closure - Posterior Torso

Clinical assessment of wound closure expressed as a percentage, per anatomical region

Intention to treat

Posted

Mean

Standard Deviation

% wound closure

1, 2, 3, 6, 12 months after application of SSG

Wounds treated with BTM

ID	Title	Description
OG000	Biodegradable Temporizing Matrix (BTM)	The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Units	Counts
Participants	OG000

Secondary

Wound Closure - Right Lower Limb

Clinical assessment of wound closure expressed as a percentage, per anatomical region

Intention to treat

Posted

Mean

Standard Deviation

% wound closure

1, 2, 3, 6, 12 months after application of SSG

Wounds treated with BTM

ID	Title	Description
OG000	Biodegradable Temporizing Matrix (BTM)	The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Units	Counts
Participants	OG000

Secondary

Ease of Use: "BTM is Easy to Use"

Operator ease of use as determined by physician survey, scored on a 1 to 5 scale, where 1 = strongly agree and 5 = strongly disagree.

A higher score means a worse outcome.

Intention to treat

Posted

Mean

Standard Deviation

score on a scale

At time of application of SSG (typically 28-35 days after application of BTM, Day 0)

Wounds treated with BTM

ID	Title	Description
OG000	Biodegradable Temporizing Matrix (BTM)	The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Units	Counts
Participants	OG000

Secondary

Ease of Use: "BTM is Easy to Apply"

Operator ease of use as determined by physician survey, scored on a 1 to 5 scale, where 1 = strongly agree and 5 = strongly disagree.

A higher score means a worse outcome.

Intention to treat

Posted

Mean

Standard Deviation

score on a scale

At time of application of SSG (typically 28-35 days after application of BTM, Day 0)

Wounds treated with BTM

ID	Title	Description
OG000	Biodegradable Temporizing Matrix (BTM)	The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Units	Counts
Participants	OG000

Secondary

Ease of Use: "BTM is Easy to Delaminate"

Operator ease of use as determined by physician survey, scored on a 1 to 5 scale, where 1 = strongly agree and 5 = strongly disagree.

A higher score means a worse outcome.

Intention to treat

Posted

Mean

Standard Deviation

score on a scale

At time of application of SSG (typically 28-35 days after application of BTM, Day 0)

Wounds treated with BTM

ID	Title	Description
OG000	Biodegradable Temporizing Matrix (BTM)	The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Units	Counts
Participants	OG000

Secondary

Ease of Use: "BTM is a Product I Would Use for Other Burn Patients"

Operator ease of use as determined by physician survey, scored on a 1 to 5 scale, where 1 = strongly agree and 5 = strongly disagree.

A higher score means a worse outcome.

Intention to treat

Posted

Mean

Standard Deviation

score on a scale

At time of application of SSG (typically 28-35 days after application of BTM, Day 0)

Wounds treated with BTM

ID	Title	Description
OG000	Biodegradable Temporizing Matrix (BTM)	The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Units	Counts
Participants	OG000

Secondary

Joint Contracture

Joint contracture after treatment, assessed by Joint Contracture Severity Scale. Joint Contracture Severity Scale is assessed per anatomical joint and assigned a value from 1 to 3, where 1 = Mild, 2 = Moderate, 3 = Severe.

Results summarized as the number of participants who had at least one joint assessed with a joint contracture of each severity grade. Where more than one joint motion was affected (e.g. knee flexion, knee extension, etc.), the motion with the most severe contracture at a specific timepoint was reported in the summary results.

Intention to treat

Posted

Count of Participants

Participants

1, 2, 3, 6, 12 months after application of BTM

ID	Title	Description
OG000	Biodegradable Temporizing Matrix (BTM)	The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Units	Counts
Participants

Secondary

Scar Severity

Scar appearance/quality assessed by the Modified Vancouver Scar Scale (mVSS), which includes 4 individual sub-scale scores of Pigmentation, Vascularity, Pliability, and Height (mm) of burn lesion and a Total of the individual sub-scale scores.

Pigmentation: 0=Normal color, 1=Hypopigmentation, 2=Hyperpigmentation, 3=Combination/Mixed Vascularity: 0=Normal, 1=Pink, 2=Red, 3=Purple. Pliability: 0=Normal, 1=Supple, 2=Yielding, 3=Firm, 4=Banding, 5=Contracture. Height (mm): 0=Normal (flat), 1='<2', 2='>2 and <5', 3='>=5' Total: Sum of individual mVSS scores. Minimum total value = 0. Maximum total value = 14.

Higher scores mean a worse outcome.

Intention to treat

Posted

Mean

Standard Deviation

Total score on a scale

1, 2, 3, 6 and 12 months after application of SSG

Wounds treated with BTM

ID	Title	Description
OG000	Biodegradable Temporizing Matrix (BTM)	The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Units

Secondary

Skin Itch

Pruritus incidence and severity assessed by Numerical Rating Scale from 0 to 10, where 0 = no itch and 10 = worst itch imaginable.

Higher scores mean a worse outcome.

Intention to treat

Posted

Mean

Standard Deviation

score on a scale

At 1, 2, 3, 6, 12 months after application of SSG

Wounds treated with BTM

ID	Title	Description
OG000	Biodegradable Temporizing Matrix	Biodegradable Temporizing Matrix (BTM) Biodegradable Temporizing Matrix: The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distention	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0003 events3 affected14 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0008 events8 affected14 at risk
Diarrhoae	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0006 events5 affected14 at risk
Dysphagia	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Gastrointestinal sounds abnormal	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Ileus	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Intestinal dilatation	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Megacolon	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0009 events8 affected14 at risk
Oral pain	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Peritoneal haematoma	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0003 events3 affected14 at risk
Abscess limb	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Aspergillus infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Candida infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0002 events2 affected14 at risk
Clostridium infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Device related infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Enterobacter infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Enterococcal infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Escherichia infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0003 events3 affected14 at risk
Fungal skin infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0002 events2 affected14 at risk
Haemophilus infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Herpes simplex	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Herpes virus infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Klebsiella infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Oral candidiasis	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Pseudomonas infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0002 events2 affected14 at risk
Purulent discharge	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0003 events2 affected14 at risk
Skin candida	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0002 events2 affected14 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Staphylococcal infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG00011 events5 affected14 at risk
Subcutaneous abscess	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Systemic candida	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0002 events2 affected14 at risk
Tinea pedis	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Urinary tract infection fungal	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0002 events2 affected14 at risk
Wound infection pseudomonas	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0003 events2 affected14 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0003 events2 affected14 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0002 events2 affected14 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Excessive granulation tissue	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Hypertrophic scar	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0006 events3 affected14 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0005 events4 affected14 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0004 events4 affected14 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0002 events2 affected14 at risk
Skin hypertrophy	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Skin hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Skin odour abnormal	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Skin ulcer haemorrhage	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Application site haematoma	General disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Asthenia	General disorders	MedDRA Version 22.0	Systematic Assessment	EG0002 events2 affected14 at risk
Chest pain	General disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Oedema peripheral	General disorders	MedDRA Version 22.0	Systematic Assessment	EG0004 events4 affected14 at risk
Pain	General disorders	MedDRA Version 22.0	Systematic Assessment	EG0003 events3 affected14 at risk
Physical deconditioning	General disorders	MedDRA Version 22.0	Systematic Assessment	EG0003 events3 affected14 at risk
Pyrexia	General disorders	MedDRA Version 22.0	Systematic Assessment	EG0005 events5 affected14 at risk
Acute stress disorder	Psychiatric disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Agitation	Psychiatric disorders	MedDRA Version 22.0	Systematic Assessment	EG0004 events4 affected14 at risk
Anxiety	Psychiatric disorders	MedDRA Version 22.0	Systematic Assessment	EG0005 events4 affected14 at risk
Delirium	Psychiatric disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Disorientation	Psychiatric disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Hallucination	Psychiatric disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Insomnia	Psychiatric disorders	MedDRA Version 22.0	Systematic Assessment	EG0008 events7 affected14 at risk
Nightmare	Psychiatric disorders	MedDRA Version 22.0	Systematic Assessment	EG0004 events4 affected14 at risk
Restlessness	Psychiatric disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Graft haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 22.0	Systematic Assessment	EG0003 events1 affected14 at risk
Incision site pruritus	Injury, poisoning and procedural complications	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Scar	Injury, poisoning and procedural complications	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Skin scar contracture	Injury, poisoning and procedural complications	MedDRA Version 22.0	Systematic Assessment	EG0004 events3 affected14 at risk
Wound	Injury, poisoning and procedural complications	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Wound necrosis	Injury, poisoning and procedural complications	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Arterial haemorrhage	Vascular disorders	MedDRA Version 22.0	Systematic Assessment	EG0002 events1 affected14 at risk
Deep vein thrombosis	Vascular disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Extremity necrosis	Vascular disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Haematoma	Vascular disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Hypertension	Vascular disorders	MedDRA Version 22.0	Systematic Assessment	EG0003 events3 affected14 at risk
Hypotension	Vascular disorders	MedDRA Version 22.0	Systematic Assessment	EG00010 events7 affected14 at risk
Pelvic vein thrombosis	Vascular disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA Version 22.0	Systematic Assessment	EG0002 events1 affected14 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Aspergillus test positive	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Blood calcium decreased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0002 events1 affected14 at risk
Blood glucose decreased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Blood magnesium decreased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Blood phosphorus decreased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0002 events1 affected14 at risk
Blood phosphorus increased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Blood potassium decreased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0009 events3 affected14 at risk
Enterococcus test positive	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Fungal test positive	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0004 events2 affected14 at risk
Haemoglobin decreased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0008 events1 affected14 at risk
Herpes simplex test positive	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Influenza virus test positive	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
International normalised ratio increased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Oxygen saturation decreased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Platelet count decreased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Pseudomonas test positive	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0002 events2 affected14 at risk
Staphylococcus test positive	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0004 events3 affected14 at risk
Trichomonal test positive	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Urine output decreased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0005 events3 affected14 at risk
Weight decreased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 22.0	Systematic Assessment	EG0003 events3 affected14 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Metabolic alkalosis	Metabolism and nutrition disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA Version 22.0	Systematic Assessment	EG0005 events4 affected14 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA Version 22.0	Systematic Assessment	EG0002 events2 affected14 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA Version 22.0	Systematic Assessment	EG0002 events2 affected14 at risk
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Bone lesion	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Extremity contracture	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0006 events3 affected14 at risk
Joint contracture	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0004 events4 affected14 at risk
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Atelactasis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0003 events3 affected14 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0002 events2 affected14 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Increased viscosity of bronchial secretions	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Increased viscosity of upper respiratory secretion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0005 events4 affected14 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0002 events2 affected14 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0004 events4 affected14 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0002 events2 affected14 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Atrial fibrillation	Cardiac disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Atrial flutter	Cardiac disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Tachycardia	Cardiac disorders	MedDRA Version 22.0	Systematic Assessment	EG0002 events2 affected14 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Dry eye	Eye disorders	MedDRA Version 22.0	Systematic Assessment	EG0002 events2 affected14 at risk
Eye movement disorder	Eye disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Scleral oedema	Eye disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Cognitive disorder	Nervous system disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Headache	Nervous system disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Neuralgia	Nervous system disorders	MedDRA Version 22.0	Systematic Assessment	EG0002 events2 affected14 at risk
Peroneal nerve palsy	Nervous system disorders	MedDRA Version 22.0	Systematic Assessment	EG0002 events2 affected14 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Urinary retention	Renal and urinary disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Cortisol deficiency	Endocrine disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA Version 22.0	Systematic Assessment	EG0001 events1 affected14 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA Version 22.0	Systematic Assessment	Infected pseudoaneurysm of right femoral artery	EG0001 events1 affected14 at risk
Tracheostomy malfunction	Injury, poisoning and procedural complications	MedDRA Version 22.0	Systematic Assessment	Loss of airway	EG0002 events2 affected14 at risk
Fusarium infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	Fusarium skin infection	EG0001 events1 affected14 at risk
Sepsis	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	Sepsis	EG0001 events1 affected14 at risk
Cellulitis infection right lower limb	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	Cellulitis infection right lower limb	EG0001 events1 affected14 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	Intraperitoneal bleeding	EG0001 events1 affected14 at risk
Arterial rupture	Vascular disorders	MedDRA Version 22.0	Systematic Assessment	Right femoral artery blowout, s/p right femoral artery patch angioplasty with autogenous vein and sartorius muscle flap	EG0001 events1 affected14 at risk
Joint contracture on left shoulder	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Systematic Assessment	Joint contracture	EG0001 events1 affected14 at risk