Study of the Combination of a Cyanoacrylate and Surgical... | NCT00467857

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
InteguSeal* and standard surgical preparation solutions	Active Comparator	InteguSeal* microbial skin sealant was applied to surgical sites prior to incision after standard surgical skin preparation in patients undergoing coronary artery bypass graft (CABG) surgery	Procedure: InteguSeal* skin sealant and standard surgical preparation
Standard surgical skin preparation alone	Other	Prior to incision, standard surgical skin preparation in patients undergoing coronary artery bypass graft (CABG) surgery	Other: Standard preoperative skin preparation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
InteguSeal* skin sealant and standard surgical preparation	Procedure	Surgical skin preparation prior to incision using InteguSeal* skin sealant following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Sternal Site	Number of unique bacterial colony types isolated from samples of skin flora taken from the sternal incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.	Before surgery (prior to skin preparation) and after surgery (after closing fascia)
Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Graft Site	Number of unique bacterial colony types isolated from samples of skin flora taken from the graft incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.	Before surgery (prior to skin preparation) and after surgery (after closing fascia)

Secondary Outcomes

Measure	Description	Time Frame
Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Sternal Site	Total bacterial counts from samples of skin flora from the sternal incision site after surgery minus before surgery (prior to skin prep).	Before surgery (prior to skin preparation) and after surgery (after closing fascia)
Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Graft Site

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Scheduled for an elective Coronary Artery Bypass Graft (CABG) surgical procedure with median sternotomy utilizing either the saphenous vein and/or radial artery as one of the graft sites within 28 days of the screening date, as documented by a Cardiothoracic Surgeon who is the Principal Investigator or sub-investigator. This includes subjects who are also receiving internal mammary artery grafts in addition to saphenous vein and/or radial artery grafts.
The skin near or around the proposed incision sites should be intact.

Exclusion Criteria:

Known sensitivity or allergy to cyanoacrylate, isopropyl alcohol, iodine or iodine-containing products or tape allergies.
Female subjects that are nursing or actively lactating.
Abnormal skin condition adjacent to or at the surgical incision sites.
Hair removal at the surgical sites prior to entrance to the operating suite.
Use of antimicrobial impregnated incise drapes (i.e. Ioban®).
Hospital stay of >14 days immediately prior to scheduled CABG surgery.
Use of chemotherapy agents, within 30 days prior to Visit 1 screening.
Scheduled for additional chemotherapy for the duration of the study.
Known positive Human Immunodeficiency Virus (HIV) with a CD4 count < 350 mm3. If HIV status is not known, the subject is not excluded.
Currently taking antibiotics for an infection (within 30 days prior to Visit 1).
Has had therapeutic radiation to the chest within 30 days of visit 1. This does not include subjects who receive chest xrays.
Pre-operatively scheduled to have concomitant procedures with coronary artery bypass graft procedure.
Scheduled to receive only one incision (a median sternotomy) without a planned saphenous vein graft and/or a radial artery graft donor site.
Renal dialysis currently or within 30 days of visit 1.
Morbid Obesity (Subjects with a Body Mass Index (BMI) > 37).
Neutropenia (absolute neutrophil count <1000/mm3).
Pre-operatively on an intra-aortic balloon pump or mechanical assist device.
Has received an experimental drug or used an experimental medical device within 30 days prior to Visit 1.
Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center.
Any condition, which in the opinion of the investigator would exclude the subject from the study.
Patients on steroid use for more than 1 week within 30 days of visit 1.
Patients on immunosuppressive therapy within 30 days of visit 1.
Depilatory creams with containing antibiotics.

Name	Affiliation	Role
Charlotte D Owens, MD	Kimberly-Clark Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Wellstar Health Systems		Marietta	Georgia	30060	United States
Heart Institute- Dept of Thoracic Surgery

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16834542	Background	Dohmen PM. Influence of skin flora and preventive measures on surgical site infection during cardiac surgery. Surg Infect (Larchmt). 2006;7 Suppl 1:S13-7. doi: 10.1089/sur.2006.7.s1-13.
16834544	Background	Malangoni MA, Cheadle WG, Dodson TF, Dohmen PM, Jones D, Katariya K, Kolvekar S, Urban JA. New opportunities for reducing risk of surgical site infection. Roundtable discussion. Surg Infect (Larchmt). 2006;7 Suppl 1:S23-39. doi: 10.1089/sur.2006.7.s1-23. No abstract available.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	InteguSeal* and Standard Surgical Preparation Solutions	Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	InteguSeal* and Standard Surgical Preparation Solutions	Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
BG001	Standard Surgical Preparation Solutions	Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000146 BG001147 BG002293

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00063.18± 8.53 BG00162.94± 9.97 BG00263.06± 9.28

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00026 BG00118 BG002

Height

Data for n=145 microbial skin sealant, n=147 control

Mean

Standard Deviation

meters

Title

Denominators

Categories

Title	Measurements
	BG0001.67± 0.10 BG0011.66± 0.09 BG002

Weight

Mean

Standard Deviation

kilograms

Title

Denominators

Categories

Title	Measurements
	BG00076.2± 14.4 BG00173.8± 12.0 BG002

Body Mass Index (BMI)

Results for n=145 microbial skin sealant, n=147 control.

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00027.3± 4.0 BG00126.6± 3.4

Obesity

Number

participants

Title

Denominators

Categories

Obese (BMI>30.0 kg/m^2)

Title	Measurements
	BG00040 BG00120 BG002

Diabetes mellitus, type 1 or 2

Number

participants

Title

Denominators

Categories

present

Title	Measurements
	BG00049 BG00149 BG002

Tobacco Use

Number

participants

Title

Denominators

Categories

yes

Title	Measurements
	BG00084 BG00191 BG002

Alcohol Use

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00042 BG00152 BG002

New York Heart Association (NYHA) Functional Classification

The NYHA Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity:

Class I: No symptoms and no limitation in ordinary physical activity.

Class II: Mild symptoms and slight limitation during ordinary activity. Comfortable at rest.

Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.

Class IV: Severe limitations. Experiences symptoms even while at rest.

Number

participants

Title

Denominators

Categories

Class I

Title	Measurements
	BG00029 BG001

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

Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Sternal Site

Number of unique bacterial colony types isolated from samples of skin flora taken from the sternal incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.

Per protocol

Posted

Mean

Standard Deviation

isolates

Before surgery (prior to skin preparation) and after surgery (after closing fascia)

ID	Title	Description
OG000	InteguSeal* and Standard Surgical Preparation Solutions	Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
OG001	Standard Surgical Preparation Solutions	Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

Units	Counts
Participants	OG000116 OG001127

Title

Denominators

Categories

Title	Measurements
	OG000-1.34± 1.0 OG001-1.31± 1.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The sample size determination was selected to achieve 80% power to detect an absolute 10% difference between the two treatment groups in proportion of qualitative reduction in representative skin flora, at a significance level (alpha) of 0.05 using a two-sided z-test with continuity correction.	Wilcoxon-Rank Sum Test		0.655							95						No	Superiority or Other

Secondary

Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Sternal Site

Total bacterial counts from samples of skin flora from the sternal incision site after surgery minus before surgery (prior to skin prep).

Per protocol

Posted

Mean

Standard Deviation

log CFU/mL

Before surgery (prior to skin preparation) and after surgery (after closing fascia)

ID	Title	Description
OG000	InteguSeal* and Standard Surgical Preparation Solutions	Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
OG001	Standard Surgical Preparation Solutions	Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

Units	Counts
Participants

Secondary

Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Graft Site

Total bacterial counts from samples of skin flora from the graft incision site after surgery minus before surgery (prior to skin prep).

Per protocol

Posted

Mean

Standard Deviation

log CFU/mL

Before surgery (prior to skin preparation) and after surgery (after closing fascia)

ID	Title	Description
OG000	InteguSeal* and Standard Surgical Preparation Solutions	Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
OG001	Standard Surgical Preparation Solutions	Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

Units	Counts
Participants

Secondary

Post-CABG Procedure Bacterial Count - Sternal Site

Total bacterial counts from samples of skin flora of the sternal incision site taken immediately following the CABG procedure.

Per protocol

Posted

Mean

Standard Deviation

log CFU/mL

Post-surgery

ID	Title	Description
OG000	InteguSeal* and Standard Surgical Preparation Solutions	Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
OG001	Standard Surgical Preparation Solutions	Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

Units	Counts
Participants	OG000

Secondary

Post-CABG Procedure Bacterial Count - Graft Site

Total bacterial counts from samples of skin flora of the graft incision site taken immediately following the CABG procedure.

Per protocol

Posted

Mean

Standard Deviation

log CFU/mL

Post-surgery

ID	Title	Description
OG000	InteguSeal* and Standard Surgical Preparation Solutions	Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
OG001	Standard Surgical Preparation Solutions	Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

Units	Counts
Participants	OG000

Secondary

Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Sternal Site

Number of unique bacterial colony types isolated from samples of skin flora from the sternal incision site immediately after the incision minus before surgery (prior to surgical skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.

Per protocol

Posted

Mean

Standard Deviation

isolates

Before surgery (prior to skin preparation) and immediately after incision

ID	Title	Description
OG000	InteguSeal* and Standard Surgical Preparation Solutions	Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
OG001	Standard Surgical Preparation Solutions	Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

Units	Counts

Secondary

Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Graft Site

Number of unique bacterial colony types isolated from samples of skin flora from the graft incision site immediately after the incision minus before surgery (prior to surgical skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.

Per protocol

Posted

Mean

Standard Deviation

isolates

Before surgery (prior to skin preparation) and immediately after incision

ID	Title	Description
OG000	InteguSeal* and Standard Surgical Preparation Solutions	Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
OG001	Standard Surgical Preparation Solutions	Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

Units	Counts

Secondary

Change in Bacterial Count From Pre-skin Preparation to Post-incision - Sternal Site

Total bacterial counts from samples of skin flora from the sternal incision site immediately after incision minus before surgery (prior to skin prep)

Per protocol

Posted

Mean

Standard Deviation

log CFU/mL

Before surgery (prior to skin preparation) and immediately after incision

ID	Title	Description
OG000	InteguSeal* and Standard Surgical Preparation Solutions	Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
OG001	Standard Surgical Preparation Solutions	Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

Units	Counts
Participants

Primary

Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Graft Site

Number of unique bacterial colony types isolated from samples of skin flora taken from the graft incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.

Per protocol

Posted

Mean

Standard Deviation

isolates

Before surgery (prior to skin preparation) and after surgery (after closing fascia)

ID	Title	Description
OG000	InteguSeal* and Standard Surgical Preparation Solutions	Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
OG001	Standard Surgical Preparation Solutions	Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

Units	Counts

Secondary

Change in Bacterial Count From Pre-skin Preparation to Post-incision - Graft Site

Total bacterial counts from samples of skin flora from the graft incision site immediately after incision minus before surgery (prior to skin prep)

Per protocol

Posted

Mean

Standard Deviation

log CFU/mL

Before surgery (prior to skin preparation) and immediately after incision

ID	Title	Description
OG000	InteguSeal* and Standard Surgical Preparation Solutions	Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
OG001	Standard Surgical Preparation Solutions	Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

Units	Counts
Participants

Secondary

Post-incision Bacterial Count - Sternal Site

Total bacterial counts from samples of skin flora of the sternal incision site taken immediately following the surgical incision

Per protocol

Posted

Mean

Standard Deviation

log CFU/mL

Immediately after surgical incision

ID	Title	Description
OG000	InteguSeal* and Standard Surgical Preparation Solutions	Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
OG001	Standard Surgical Preparation Solutions	Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

Units	Counts
Participants	OG000

Secondary

Post-incision Bacterial Count - Graft Site

Total bacterial counts from samples of skin flora of the graft incision site taken immediately following the surgical incision

Per protocol

Posted

Mean

Standard Deviation

log CFU/mL

Immediately after surgical incision

ID	Title	Description
OG000	InteguSeal* and Standard Surgical Preparation Solutions	Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
OG001	Standard Surgical Preparation Solutions	Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

Units	Counts
Participants	OG000

Secondary

Number of Patients With SSI at the Sternal Site and/or Graft Site

Number of patients who develop at least one surgical site infection at the sternal or graft site during the 30 day post-op follow-up period

Intention to treat

Posted

Number

Participants

30 days

ID	Title	Description
OG000	InteguSeal* and Standard Surgical Preparation Solutions	Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
OG001	Standard Surgical Preparation Solutions	Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

Units	Counts
Participants	OG000

Secondary

Number of Patients With Alcohol Use, Tobacco Use, or Obesity With Surgical Site Infection (SSI)

Number of patients with risk factors of alcohol use, tobacco use, or obesity who developed an SSI at the sternal and/or graft site

Subset of Intention to treat participants with alcohol use, tobacco use, or obesity

Posted

Number

Participants

30 days

ID	Title	Description
OG000	InteguSeal* and Standard Surgical Preparation Solutions	Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
OG001	Standard Surgical Preparation Solutions	Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	InteguSeal* and Standard Surgical Preparation Solutions	Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.			6	146	6	146
EG001	Standard Surgical Preparation Solutions	Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.			8	147	10	147

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Death	General disorders	MedDRA (11.0)	Systematic Assessment	EG0000 affected146 at risk EG0013 affected147 at risk
Sudden death	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected146 at risk EG0010 affected147 at risk
Incision site infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0003 affected146 at risk EG0012 affected147 at risk
Mediastinitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0002 affected146 at risk EG0012 affected147 at risk
Osteomyelitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 affected146 at risk EG0011 affected147 at risk
Wound infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 affected146 at risk EG0010 affected147 at risk
Hospitalisation	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0000 affected146 at risk EG0011 affected147 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arteriovenous graft site infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 affected146 at risk EG0010 affected147 at risk
Incision site infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0003 affected146 at risk EG0018 affected147 at risk
Mediastinitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 affected146 at risk EG0010 affected147 at risk
Osteomyelitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 affected146 at risk EG0010 affected147 at risk
Postoperative wound infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 affected146 at risk EG0011 affected147 at risk
Skin graft infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 affected146 at risk EG0011 affected147 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected146 at risk EG0010 affected147 at risk