FS VH S/D 500 S-apr in Vascular Surgery | NCT00892957

NCT00892957

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FS VH S/D 500 s-apr	Experimental	FS VH S/D 500 s-apr will be applied to the study suture line.	Biological: Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)
Manual compression with surgical gauze pads	Active Comparator	Dry gauze pads will be positioned to cover the complete study suture line.	Other: Surgical gauze pads

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)	Biological	The actual dose of FS VH S/D 500 s-apr will depend on the length of the suture line and the intensity of bleeding (but shall not exceed 4 mL FS VH S/D 500 s-apr).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.	Hemostasis at the study suture line must be maintained until closure of the surgical wound.	4 minutes post start of treatment application
Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding	Investigators were shown videos of bleeding severities to standardize assessments. Moderate bleeding defined as: Either >25% of the suture line bleeds, or ≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or 1 pulsatile suture line bleeding was present.	4 minutes post start of treatment application
Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding	Investigators were shown videos of bleeding severities to standardize assessments. Severe bleeding defined as: Either >50% of the suture line bleeds, or ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or >1 pulsatile suture line bleeding was present, or ≥1 spurting suture line bleeding was present.	4 minutes post start of treatment application

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Achieved Hemostasis at 6 Minutes Post Treatment Application	Hemostasis at the study suture line must be maintained until closure of the surgical wound.	6 minutes post start of treatment application
Percentage of Participants Who Achieved Hemostasis at 10 Minutes Post Treatment Application

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Preoperative inclusion criteria:

Subjects undergoing vascular surgery (ie, conduit placement with an ePTFE graft), including arterio-arterial bypasses, including:
- axillo-femoral
- axillo-bifemoral
- aorto-bifemoral
- ilio-femoral
- femoro-femoral
- ilio-popliteal
- femoro-popliteal (including below knee)
- femoro-tibial vessel bypass
- arterio-venous shunting for dialysis access in the upper or lower extremity
Signed informed consent
Subject is of childbearing potential, presents with a negative serum or urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study.
Subject is willing and able to comply with the requirements of the protocol.

Intraoperative inclusion criterion:

Suture line bleeding eligible for study treatment is present after surgical hemostasis (ie, suturing). (A definition of eligible suture line bleeding is provided in the study protocol.)

Exclusion Criteria:

Preoperative exclusion criteria:

Other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed)
Congenital coagulation disorders
Prior kidney transplantation
Heparin-induced thrombocytopenia
Known hypersensitivity to heparin
Known hypersensitivity to aprotinin or other components of the product
Known severe congenital or acquired immunodeficiency (eg, HIV infection or long-term treatment with immunosuppressive drugs (eg, organ transplantation patients)
Prior radiation therapy to the operating field
Severe local inflammation at the operating field
Subject is pregnant or lactating at the time of enrollment
Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
Subject has previously participated in this study (Protocol No.: 550801), ie, each subject can only be enrolled once.

Intraoperative Exclusion Criteria:

Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure
Intraoperative change in planned surgical procedure, which results in subject no longer meeting preoperative inclusion and/or exclusion criteria, (eg, abandonment of ePTFE graft placement)

Contacts/Locations Module

Name	Affiliation	Role
Isabella Presch, MD, MBA	Baxter Innovations GmbH	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22633423	Background	Saha SP, Muluk S, Schenk W 3rd, Dennis JW, Ploder B, Grigorian A, Presch I, Goppelt A. A prospective randomized study comparing fibrin sealant to manual compression for the treatment of anastomotic suture-hole bleeding in expanded polytetrafluoroethylene grafts. J Vasc Surg. 2012 Jul;56(1):134-41. doi: 10.1016/j.jvs.2012.01.009. Epub 2012 May 25.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	FS VH S/D 500 S-apr	FS VH S/D 500 s-apr will be applied to the study suture line.
FG001	Control - Manual Compression With Surgical Gauze Pads	Dry gauze pads will be positioned to cover the complete study suture line.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	FS VH S/D 500 S-apr	FS VH S/D 500 s-apr will be applied to the study suture line.
BG001	Control - Manual Compression With Surgical Gauze Pads	Dry gauze pads will be positioned to cover the complete study suture line.
BG002	Total	Total of all reporting groups

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
	BG00062.5± 12.6 BG00166.3± 11.5 BG00264.4± 12.2

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00040 BG00133 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00070 BG00170 BG002

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

Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.

Hemostasis at the study suture line must be maintained until closure of the surgical wound.

Intent to Treat

Posted

Number

95% Confidence Interval

Percentage of participants

4 minutes post start of treatment application

ID	Title	Description
OG000	FS VH S/D 500 S-apr	FS VH S/D 500 s-apr was applied to the study suture line
OG001	Control - Manual Compression With Surgical Gauze	Dry gauze pads were positioned to cover the complete study suture line

Units	Counts
Participants	OG00070 OG00170

Title

Denominators

Categories

Title	Measurements
	OG00062.9(51.2 to 73.6) OG00131.4(21.4 to 42.8)

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		Likelihood ratio chi-square test		<0.0001						1-Sided	95						No	Superiority or Other

Secondary

Percentage of Participants Who Achieved Hemostasis at 6 Minutes Post Treatment Application

Hemostasis at the study suture line must be maintained until closure of the surgical wound.

Intent to treat

Posted

Number

95% Confidence Interval

percentage of participants

6 minutes post start of treatment application

ID	Title	Description
OG000	FS VH S/D 500 S-apr	FS VH S/D 500 s-apr was applied to the study suture line
OG001	Control - Manual Compression With Surgical Gauze	Dry gauze pads were positioned to cover the complete study suture line

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Achieved Hemostasis at 10 Minutes Post Treatment Application

Hemostasis at the study suture line must be maintained until closure of the surgical wound.

Intent to treat

Posted

Number

95% Confidence Interval

percentage of participants

10 minutes post start of treatment application

ID	Title	Description
OG000	FS VH S/D 500 S-apr	FS VH S/D 500 s-apr was applied to the study suture line
OG001	Control - Manual Compression With Surgical Gauze	Dry gauze pads were positioned to cover the complete study suture line

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Intraoperative Rebleeding After Hemostasis at Study Suture Line

Intraoperative rebleeding at the study suture line after occurrence of hemostasis.

Intent to treat

Posted

Number

95% Confidence Interval

percentage of participants

Intraoperative day 0

ID	Title	Description
OG000	FS VH S/D 500 S-apr	FS VH S/D 500 s-apr was applied to the study suture line
OG001	Control - Manual Compression With Surgical Gauze	Dry gauze pads were positioned to cover the complete study suture line

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Postoperative Rebleeding

Any rebleeding requiring surgical re-exploration

Intent to treat

Posted

Number

95% Confidence Interval

percentage of participants

Postoperative through day 30 ± 5

ID	Title	Description
OG000	FS VH S/D 500 S-apr	FS VH S/D 500 s-apr was applied to the study suture line
OG001	Control - Manual Compression With Surgical Gauze	Dry gauze pads were positioned to cover the complete study suture line

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Graft Occlusion

Determined clinically and defined as absence of blood flow through the graft.

Safety Analysis Set

Posted

Number

95% Confidence Interval

percentage of participants

post-op discharge/day 1, post-op day 14 and day 30

ID	Title	Description
OG000	FS VH S/D 500 S-apr	FS VH S/D 500 s-apr was applied to the study suture line
OG001	Control - Manual Compression With Surgical Gauze	Dry gauze pads were positioned to cover the complete study suture line

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Infection at the Surgical Site

Safety Analysis Set

Posted

Number

95% Confidence Interval

percentage of participants

post-op discharge/day 1, post-op day 14 and day 30

ID	Title	Description
OG000	FS VH S/D 500 S-apr	FS VH S/D 500 s-apr was applied to the study suture line
OG001	Control - Manual Compression With Surgical Gauze	Dry gauze pads were positioned to cover the complete study suture line

Units	Counts
Participants	OG000

Secondary

Number of Participants With Infections by Grade

Infections were recorded according to:

Grade I: only dermis affected
Grade II: infection invades subcutaneous region but not the arterial implant
Grade III: the arterial implant is infected

Safety Analysis Set

Posted

Number

participants

post-op discharge/day 1, post-op day 14 and day 30

ID	Title	Description
OG000	FS VH S/D 500 S-apr	FS VH S/D 500 s-apr was applied to the study suture line
OG001	Control - Manual Compression With Surgical Gauze	Dry gauze pads were positioned to cover the complete study suture line

Units	Counts
Participants	OG000

Secondary

Vital Signs: Systolic and Diastolic Blood Pressure (BP)- Preoperative Baseline

Safety Analysis Set

Posted

Median

Full Range

mm Hg

Within 14 days prior to date of surgery

ID	Title	Description
OG000	FS VH S/D 500 S-apr	FS VH S/D 500 s-apr was applied to the study suture line
OG001	Control - Manual Compression With Surgical Gauze	Dry gauze pads were positioned to cover the complete study suture line

Units	Counts
Participants	OG000

Secondary

Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure

Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14

Safety Analysis Set

Posted

Median

Full Range

percent change

Within 14 days prior to surgery through postoperative day 14

ID	Title	Description
OG000	FS VH S/D 500 S-apr: Preop Baseline - Intraoperative Day 0	FS VH S/D 500 s-apr was applied to the study suture line
OG001	Control: Preop Baseline - Intraoperative Day 0	Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
OG002	FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1	FS VH S/D 500 s-apr was applied to the study suture line
OG003	Control: Preop Baseline - Postoperative Day 1	Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line

Secondary

Vital Signs: Heart Rate - Preoperative Baseline

Safety Analysis Set

Posted

Median

Full Range

beats per minute

Within 14 days prior to date of surgery

ID	Title	Description
OG000	FS VH S/D 500 S-apr	FS VH S/D 500 s-apr was applied to the study suture line
OG001	Control - Manual Compression With Surgical Gauze	Dry gauze pads were positioned to cover the complete study suture line

Units	Counts
Participants	OG000

Secondary

Percent Change in Vital Signs: Heart Rate

Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14

Safety Analysis Set

Posted

Median

Full Range

percent change

Within 14 days prior to surgery through postoperative day 14

ID	Title	Description
OG000	FS VH S/D 500 S-apr: Preop Baseline - Intraoperative Day 0	FS VH S/D 500 s-apr was applied to the study suture line
OG001	Control: Preop Baseline - Intraoperative Day 0	Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
OG002	FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1	FS VH S/D 500 s-apr was applied to the study suture line
OG003	Control: Preop Baseline - Postoperative Day 1	Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line

Secondary

Vital Signs: Respiratory Rate - Preoperative Baseline

Safety Analysis Set

Posted

Median

Full Range

breaths per minute

Within 14 days prior to date of surgery

ID	Title	Description
OG000	FS VH S/D 500 S-apr	FS VH S/D 500 s-apr was applied to the study suture line
OG001	Control - Manual Compression With Surgical Gauze	Dry gauze pads were positioned to cover the complete study suture line

Units	Counts
Participants	OG000

Secondary

Percent Change in Vital Signs: Respiratory Rate

Percent Change in Heart Rate Measured as: Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14

Safety Analysis Set

Posted

Median

Full Range

percent change

Within 14 days prior to surgery through postoperative day 14

ID	Title	Description
OG000	FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1	FS VH S/D 500 s-apr was applied to the study suture line
OG001	Control: Preop Baseline - Postoperative Day 1	Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
OG002	FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14	FS VH S/D 500 s-apr was applied to the study suture line
OG003	Control: Preop Baseline - Postoperative Day 14	Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line

Secondary

Laboratory Values Over Time: Hemoglobin

Safety Analysis Data Set

Posted

Median

Full Range

g/dL

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS VH S/D 500 S-apr: Baseline	FS VH S/D 500 s-apr, 120 seconds polymerization
OG001	FS VH S/D 500 S-apr: Postoperative Day 14	FS VH S/D 500 s-apr, 120 seconds polymerization
OG002	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG003	Control Group: Postoperative Day 14	Manual compression with surgical gauze pads

Units	Counts
Participants

Secondary

Laboratory Values Over Time: Hematocrit

Safety Analysis Data Set

Posted

Median

Full Range

percentage of red blood cells in blood

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS VH S/D 500 S-apr: Baseline	FS VH S/D 500 s-apr, 120 seconds polymerization
OG001	FS VH S/D 500 S-apr: Postoperative Day 14	FS VH S/D 500 s-apr, 120 seconds polymerization
OG002	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG003	Control Group: Postoperative Day 14	Manual compression with surgical gauze pads

Units	Counts
Participants

Secondary

Laboratory Values Over Time: Erythrocytes

Safety Analysis Data Set

Posted

Median

Full Range

x10^6/µl

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS VH S/D 500 S-apr: Baseline	FS VH S/D 500 s-apr, 120 seconds polymerization
OG001	FS VH S/D 500 S-apr: Postoperative Day 14	FS VH S/D 500 s-apr, 120 seconds polymerization
OG002	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG003	Control Group: Postoperative Day 14	Manual compression with surgical gauze pads

Units	Counts
Participants

Secondary

Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes

Safety Analysis Data Set

Posted

Median

Full Range

x10^3/µl

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS VH S/D 500 S-apr: Baseline	FS VH S/D 500 s-apr, 120 seconds polymerization
OG001	FS VH S/D 500 S-apr: Postoperative Day 14	FS VH S/D 500 s-apr, 120 seconds polymerization
OG002	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG003	Control Group: Postoperative Day 14	Manual compression with surgical gauze pads

Units	Counts
Participants

Secondary

Laboratory Values Over Time: Platelets

Safety Analysis Data Set

Posted

Median

Full Range

x10^3/µl

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS VH S/D 500 S-apr: Baseline	FS VH S/D 500 s-apr, 120 seconds polymerization
OG001	FS VH S/D 500 S-apr: Postoperative Day 14	FS VH S/D 500 s-apr, 120 seconds polymerization
OG002	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG003	Control Group: Postoperative Day 14	Manual compression with surgical gauze pads

Units	Counts
Participants

Secondary

Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)

Safety Analysis Data Set

Posted

Median

Full Range

mg/dL

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS VH S/D 500 S-apr: Baseline	FS VH S/D 500 s-apr, 120 seconds polymerization
OG001	FS VH S/D 500 S-apr: Postoperative Day 14	FS VH S/D 500 s-apr, 120 seconds polymerization
OG002	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG003	Control Group: Postoperative Day 14	Manual compression with surgical gauze pads

Units	Counts
Participants

Secondary

Laboratory Values Over Time: Alanine Aminotransferase (ALT)

Safety Analysis Data Set

Posted

Median

Full Range

U/L

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS VH S/D 500 S-apr: Baseline	FS VH S/D 500 s-apr, 120 seconds polymerization
OG001	FS VH S/D 500 S-apr: Postoperative Day 14	FS VH S/D 500 s-apr, 120 seconds polymerization
OG002	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG003	Control Group: Postoperative Day 14	Manual compression with surgical gauze pads

Units	Counts
Participants

Secondary

Laboratory Values Over Time: Aspartate Aminotransferase (AST)

Safety Analysis Data Set

Posted

Median

Full Range

U/L

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS VH S/D 500 S-apr: Baseline	FS VH S/D 500 s-apr, 120 seconds polymerization
OG001	FS VH S/D 500 S-apr: Postoperative Day 14	FS VH S/D 500 s-apr, 120 seconds polymerization
OG002	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG003	Control Group: Postoperative Day 14	Manual compression with surgical gauze pads

Units	Counts
Participants

Secondary

Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)

Safety Analysis Data Set

Posted

Median

Full Range

seconds

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS VH S/D 500 S-apr: Baseline	FS VH S/D 500 s-apr, 120 seconds polymerization
OG001	FS VH S/D 500 S-apr: Postoperative Day 14	FS VH S/D 500 s-apr, 120 seconds polymerization
OG002	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG003	Control Group: Postoperative Day 14	Manual compression with surgical gauze pads

Units	Counts
Participants

Secondary

Laboratory Values Over Time: International Normalized Ratio(INR)

Safety Analysis Data Set

Posted

Median

Full Range

ratio

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS VH S/D 500 S-apr: Baseline	FS VH S/D 500 s-apr, 120 seconds polymerization
OG001	FS VH S/D 500 S-apr: Postoperative Day 14	FS VH S/D 500 s-apr, 120 seconds polymerization
OG002	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG003	Control Group: Postoperative Day 14	Manual compression with surgical gauze pads

Units	Counts
Participants

Primary

Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding

Investigators were shown videos of bleeding severities to standardize assessments.

Moderate bleeding defined as:

Either >25% of the suture line bleeds, or
≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or
1 pulsatile suture line bleeding was present.

Intent to Treat

Posted

Number

95% Confidence Interval

percentage of participants

4 minutes post start of treatment application

ID	Title	Description
OG000	FS VH S/D 500 S-apr	FS VH S/D 500 s-apr was applied to the study suture line
OG001	Control - Manual Compression With Surgical Gauze	Dry gauze pads were positioned to cover the complete study suture line

Units	Counts
Participants	OG000

Primary

Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding

Investigators were shown videos of bleeding severities to standardize assessments.

Severe bleeding defined as:

Either >50% of the suture line bleeds, or
≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or
>1 pulsatile suture line bleeding was present, or
≥1 spurting suture line bleeding was present.

Intent to Treat

Posted

Number

95% Confidence Interval

percentage of participants

4 minutes post start of treatment application

ID	Title	Description
OG000	FS VH S/D 500 S-apr	FS VH S/D 500 s-apr was applied to the study suture line
OG001	Control - Manual Compression With Surgical Gauze	Dry gauze pads were positioned to cover the complete study suture line

Units	Counts
Participants	OG000

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	FS VH S/D 500 S-apr	FS VH S/D 500 s-apr will be applied to the study suture line.			20	70	14	70
EG001	Control - Manual Compression With Surgical Gauze Pads	Dry gauze pads will be positioned to cover the complete study suture line.			18	70	7	70

Serious Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0010 events0 affected70 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0010 events0 affected70 at risk
Constipation	Gastrointestinal disorders	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0010 events0 affected70 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0010 events0 affected70 at risk
Non-cardiac chest pain	General disorders	MedDRA (Unspecified)	EG0002 events2 affected70 at risk EG0010 events0 affected70 at risk
Thrombosis in device	General disorders	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0010 events0 affected70 at risk
Appendicitis perforated	Infections and infestations	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0010 events0 affected70 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0011 events1 affected70 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0010 events0 affected70 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0010 events0 affected70 at risk
Postoperative wound infection	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0010 events0 affected70 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0010 events0 affected70 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0012 events2 affected70 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0004 events2 affected70 at risk EG0012 events2 affected70 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0010 events0 affected70 at risk
Ischaemic neuropathy	Nervous system disorders	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0011 events1 affected70 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0010 events0 affected70 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0010 events0 affected70 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0012 events2 affected70 at risk
Arterial thrombosis limb	Vascular disorders	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0010 events0 affected70 at risk
Haematoma	Vascular disorders	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0010 events0 affected70 at risk
Steal syndrome	Vascular disorders	MedDRA (Unspecified)	EG0001 events1 affected70 at risk EG0010 events0 affected70 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (Unspecified)	EG0000 events0 affected70 at risk EG0011 events1 affected70 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (Unspecified)	EG0000 events0 affected70 at risk EG0011 events1 affected70 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA (Unspecified)	EG0000 events0 affected70 at risk EG0011 events1 affected70 at risk
Multi-organ failure	General disorders	MedDRA (Unspecified)	EG0000 events0 affected70 at risk EG0011 events1 affected70 at risk
Sepsis	Infections and infestations	MedDRA (Unspecified)	EG0000 events0 affected70 at risk EG0011 events1 affected70 at risk
Urinary tract infection	Infections and infestations	MedDRA (Unspecified)	EG0000 events0 affected70 at risk EG0011 events1 affected70 at risk
Drug toxicity	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0000 events0 affected70 at risk EG0011 events1 affected70 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0000 events0 affected70 at risk EG0011 events1 affected70 at risk
Incision site cellulitis	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0000 events0 affected70 at risk EG0011 events1 affected70 at risk
International normalised ratio increased	Investigations	MedDRA (Unspecified)	EG0000 events0 affected70 at risk EG0011 events1 affected70 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	EG0000 events0 affected70 at risk EG0011 events1 affected70 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	EG0000 events0 affected70 at risk EG0011 events1 affected70 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	EG0000 events0 affected70 at risk EG0012 events1 affected70 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	EG0000 events0 affected70 at risk EG0011 events1 affected70 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Oedema peripheral	General disorders	MedDRA (Unspecified)	EG0008 events7 affected70 at risk EG0015 events4 affected70 at risk
Operative haemorrhage	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0005 events4 affected70 at risk EG0012 events1 affected70 at risk
Hypotension	Vascular disorders	MedDRA (Unspecified)	EG0005 events4 affected70 at risk EG0013 events2 affected70 at risk

ID	Term
D015718	Fibrin Tissue Adhesive
D012997	Solvents
D013917	Thrombin
D026503	Low Density Lipoprotein Receptor-Related Protein-1

Ancestor Terms

ID	Term
D005337	Fibrin
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D020313	Specialty Uses of Chemicals
D020164	Chemical Actions and Uses
D012697	Serine Endopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases
D004798	Enzymes
D045762	Enzymes and Coenzymes
D057057	Serine Proteases
D001779	Blood Coagulation Factors
D001685	Biological Factors
D026502	LDL-Receptor Related Proteins
D011973	Receptors, LDL
D018110	Receptors, Lipoprotein
D011956	Receptors, Cell Surface
D008565	Membrane Proteins

OG00070
OG00155
OG00267
OG00357

OG00070
OG00155
OG00266
OG00357

OG00070
OG00155
OG00267
OG00357

OG00064
OG00152
OG00267
OG00355

OG00070
OG00157
OG00269
OG00357

OG00069
OG00156
OG00265
OG00357

OG00058
OG00154
OG00263
OG00356

OG00065
OG00152
OG00259
OG00353

OG00066
OG00152
OG00259
OG00353

OG004-2.64(-40.2 to 58.2)

OG005-7.30(-50.5 to 41.4)

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States