Trial Outcomes & Findings for FS VH S/D 500 S-apr in Vascular Surgery (NCT NCT00892957)

NCT ID: NCT00892957

Last Updated: 2012-11-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 176 participants
• Primary outcome timeframe: 4 minutes post start of treatment application
• Results posted on: 2012-11-27

Participant Flow

Patients were enrolled at 24 clinical sites in the United States, beginning July 2009 and completing in October 2010

176 participants were enrolled. 32 were screen failures. 1 was withdrawn by investigator (study coordinator not available to collect data), 2 participants requested withdrawal, 1 participant died prior to screening and prior to receiving study treatment. Therefore, 140 of the 176 enrolled were randomized.

Participant milestones

Measure	FS VH S/D 500 S-apr FS VH S/D 500 s-apr will be applied to the study suture line.	Control - Manual Compression With Surgical Gauze Pads Dry gauze pads will be positioned to cover the complete study suture line.
Intraoperative Day 0 STARTED	70	70
Intraoperative Day 0 COMPLETED	70	70
Intraoperative Day 0 NOT COMPLETED	0	0
Postoperative Day 1 Assessment STARTED	70	70
Postoperative Day 1 Assessment COMPLETED	70	70
Postoperative Day 1 Assessment NOT COMPLETED	0	0
Between Postoperative Day 1 and Day 14 STARTED	70	70
Between Postoperative Day 1 and Day 14 COMPLETED	70	66
Between Postoperative Day 1 and Day 14 NOT COMPLETED	0	4
Postoperative Day 14 Assessment STARTED	68	66
Postoperative Day 14 Assessment COMPLETED	68	66
Postoperative Day 14 Assessment NOT COMPLETED	0	0
Postoperative Day 30 Assessment STARTED	70	66
Postoperative Day 30 Assessment COMPLETED	70	66
Postoperative Day 30 Assessment NOT COMPLETED	0	0

Reasons for withdrawal

Measure	FS VH S/D 500 S-apr FS VH S/D 500 s-apr will be applied to the study suture line.	Control - Manual Compression With Surgical Gauze Pads Dry gauze pads will be positioned to cover the complete study suture line.
Between Postoperative Day 1 and Day 14 Death	0	2
Between Postoperative Day 1 and Day 14 Lost to Follow-up	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	FS VH S/D 500 S-apr n=70 Participants FS VH S/D 500 s-apr will be applied to the study suture line.	Control - Manual Compression With Surgical Gauze Pads n=70 Participants Dry gauze pads will be positioned to cover the complete study suture line.	Total n=140 Participants Total of all reporting groups
Age Continuous	62.5 years STANDARD_DEVIATION 12.6 • n=5 Participants	66.3 years STANDARD_DEVIATION 11.5 • n=7 Participants	64.4 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	33 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	37 Participants n=7 Participants	67 Participants n=5 Participants
Region of Enrollment United States	70 participants n=5 Participants	70 participants n=7 Participants	140 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 minutes post start of treatment application

Population: Intent to Treat

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

Outcome measures

Measure	FS VH S/D 500 S-apr n=70 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=70 Participants Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 1 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.	62.9 Percentage of participants Interval 51.2 to 73.6	31.4 Percentage of participants Interval 21.4 to 42.8	—	—	—	—

PRIMARY outcome

Timeframe: 4 minutes post start of treatment application

Population: Intent to Treat

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.

Outcome measures

Measure	FS VH S/D 500 S-apr n=29 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=27 Participants Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 1 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding	75.9 percentage of participants Interval 58.5 to 88.8	48.1 percentage of participants Interval 30.1 to 66.5	—	—	—	—

PRIMARY outcome

Timeframe: 4 minutes post start of treatment application

Population: Intent to Treat

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.

Outcome measures

Measure	FS VH S/D 500 S-apr n=41 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=42 Participants Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 1 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding	53.7 percentage of participants Interval 38.5 to 68.4	20.9 percentage of participants Interval 10.7 to 34.6	—	—	—	—

SECONDARY outcome

Timeframe: 6 minutes post start of treatment application

Population: Intent to treat

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

Outcome measures

Measure	FS VH S/D 500 S-apr n=70 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=70 Participants Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 1 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Percentage of Participants Who Achieved Hemostasis at 6 Minutes Post Treatment Application	71.4 percentage of participants Interval 60.2 to 81.1	42.9 percentage of participants Interval 31.7 to 54.6	—	—	—	—

SECONDARY outcome

Timeframe: 10 minutes post start of treatment application

Population: Intent to treat

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

Outcome measures

Measure	FS VH S/D 500 S-apr n=70 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=70 Participants Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 1 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Percentage of Participants Who Achieved Hemostasis at 10 Minutes Post Treatment Application	75.7 percentage of participants Interval 64.9 to 84.7	55.7 percentage of participants Interval 44.0 to 67.0	—	—	—	—

SECONDARY outcome

Timeframe: Intraoperative day 0

Population: Intent to treat

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

Outcome measures

Measure	FS VH S/D 500 S-apr n=70 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=70 Participants Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 1 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Percentage of Participants With Intraoperative Rebleeding After Hemostasis at Study Suture Line	5.7 percentage of participants Interval 1.8 to 12.8	1.4 percentage of participants Interval 0.1 to 6.1	—	—	—	—

SECONDARY outcome

Timeframe: Postoperative through day 30 ± 5

Population: Intent to treat

Any rebleeding requiring surgical re-exploration

Outcome measures

Measure	FS VH S/D 500 S-apr n=70 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=70 Participants Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 1 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Percentage of Participants With Postoperative Rebleeding	0 percentage of participants Interval 0.0 to 5.1	0 percentage of participants Interval 0.0 to 5.1	—	—	—	—

SECONDARY outcome

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

Population: Safety Analysis Set

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

Outcome measures

Measure	FS VH S/D 500 S-apr n=70 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=70 Participants Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 1 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Percentage of Participants With Graft Occlusion	7.1 percentage of participants Interval 2.6 to 14.7	11.4 percentage of participants Interval 5.4 to 20.2	—	—	—	—

SECONDARY outcome

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

Population: Safety Analysis Set

Outcome measures

Measure	FS VH S/D 500 S-apr n=70 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=70 Participants Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 1 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Percentage of Participants With Infection at the Surgical Site	10.0 percentage of participants Interval 4.4 to 18.4	7.1 percentage of participants Interval 2.6 to 14.7	—	—	—	—

SECONDARY outcome

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

Population: Safety Analysis Set

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

Outcome measures

Measure	FS VH S/D 500 S-apr n=70 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=70 Participants Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 1 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Number of Participants With Infections by Grade Grade I	5 participants	3 participants	—	—	—	—
Number of Participants With Infections by Grade Grade II	2 participants	1 participants	—	—	—	—
Number of Participants With Infections by Grade Grade III	0 participants	1 participants	—	—	—	—

SECONDARY outcome

Timeframe: Within 14 days prior to date of surgery

Population: Safety Analysis Set

Outcome measures

Measure	FS VH S/D 500 S-apr n=70 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=70 Participants Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 1 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Vital Signs: Systolic and Diastolic Blood Pressure (BP)- Preoperative Baseline Diastolic blood pressure	73.0 mm Hg Interval 47.0 to 104.0	76.5 mm Hg Interval 50.0 to 113.0	—	—	—	—
Vital Signs: Systolic and Diastolic Blood Pressure (BP)- Preoperative Baseline Systolic blood pressure	139.5 mm Hg Interval 86.0 to 197.0	143.5 mm Hg Interval 90.0 to 215.0	—	—	—	—

SECONDARY outcome

Timeframe: Within 14 days prior to surgery through postoperative day 14

Population: Safety Analysis Set

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

Outcome measures

Measure	FS VH S/D 500 S-apr n=70 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=70 Participants Dry gauze pads were positioned to cover the complete study suture line	FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1 n=70 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control: Preop Baseline - Postoperative Day 1 n=70 Participants Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14 n=68 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control: Preop Baseline - Postoperative Day 14 n=65 Participants Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure Systolic BP	-15.63 percent change Interval -52.5 to 44.2	-12.46 percent change Interval -52.1 to 74.3	-8.33 percent change Interval -45.5 to 34.9	-7.72 percent change Interval -40.5 to 52.7	-2.59 percent change Interval -40.5 to 35.7	-2.94 percent change Interval -39.5 to 68.9
Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure Diastolic BP (Control Postoperative Day 14 N=64)	-17.29 percent change Interval -52.9 to 50.0	-16.87 percent change Interval -49.5 to 33.9	-11.58 percent change Interval -49.4 to 55.3	-16.84 percent change Interval -56.6 to 32.8	-2.64 percent change Interval -40.2 to 58.2	-7.30 percent change Interval -50.5 to 41.4

SECONDARY outcome

Timeframe: Within 14 days prior to date of surgery

Population: Safety Analysis Set

Outcome measures

Measure	FS VH S/D 500 S-apr n=70 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=70 Participants Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 1 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Vital Signs: Heart Rate - Preoperative Baseline	75.0 beats per minute Interval 52.0 to 106.0	75.0 beats per minute Interval 41.0 to 105.0	—	—	—	—

SECONDARY outcome

Timeframe: Within 14 days prior to surgery through postoperative day 14

Population: Safety Analysis Set

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

Outcome measures

Measure	FS VH S/D 500 S-apr n=70 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=70 Participants Dry gauze pads were positioned to cover the complete study suture line	FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1 n=70 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control: Preop Baseline - Postoperative Day 1 n=70 Participants Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14 n=68 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control: Preop Baseline - Postoperative Day 14 n=65 Participants Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Percent Change in Vital Signs: Heart Rate	-6.27 percent change Interval -34.2 to 32.4	-2.12 percent change Interval -37.5 to 123.8	5.44 percent change Interval -22.9 to 82.8	4.84 percent change Interval -36.5 to 84.0	5.63 percent change Interval -20.0 to 79.3	0.00 percent change Interval -23.8 to 81.7

SECONDARY outcome

Timeframe: Within 14 days prior to date of surgery

Population: Safety Analysis Set

Outcome measures

Measure	FS VH S/D 500 S-apr n=65 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=68 Participants Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 1 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Vital Signs: Respiratory Rate - Preoperative Baseline	18.0 breaths per minute Interval 12.0 to 22.0	18.0 breaths per minute Interval 14.0 to 24.0	—	—	—	—

SECONDARY outcome

Timeframe: Within 14 days prior to surgery through postoperative day 14

Population: Safety Analysis Set

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

Outcome measures

Measure	FS VH S/D 500 S-apr n=65 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=68 Participants Dry gauze pads were positioned to cover the complete study suture line	FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1 n=62 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control: Preop Baseline - Postoperative Day 1 n=62 Participants Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Percent Change in Vital Signs: Respiratory Rate	-10.00 percent change Interval -40.0 to 66.7	-9.55 percent change Interval -40.0 to 42.9	0.00 percent change Interval -40.0 to 55.6	-6.07 percent change Interval -40.0 to 50.0	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Data Set

Outcome measures

Measure	FS VH S/D 500 S-apr n=70 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=55 Participants Dry gauze pads were positioned to cover the complete study suture line	FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1 n=67 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control: Preop Baseline - Postoperative Day 1 n=57 Participants Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Laboratory Values Over Time: Hemoglobin	12.10 g/dL Interval 9.0 to 15.4	11.60 g/dL Interval 8.1 to 14.5	12.20 g/dL Interval 9.0 to 18.4	11.80 g/dL Interval 8.2 to 15.5	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Data Set

Outcome measures

Measure	FS VH S/D 500 S-apr n=70 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=55 Participants Dry gauze pads were positioned to cover the complete study suture line	FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1 n=66 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control: Preop Baseline - Postoperative Day 1 n=57 Participants Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Laboratory Values Over Time: Hematocrit	37.0 percentage of red blood cells in blood Interval 28.0 to 50.0	36.0 percentage of red blood cells in blood Interval 28.0 to 46.0	38.5 percentage of red blood cells in blood Interval 28.0 to 58.0	37.0 percentage of red blood cells in blood Interval 24.0 to 49.0	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Data Set

Outcome measures

Measure	FS VH S/D 500 S-apr n=70 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=55 Participants Dry gauze pads were positioned to cover the complete study suture line	FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1 n=67 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control: Preop Baseline - Postoperative Day 1 n=57 Participants Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Laboratory Values Over Time: Erythrocytes	4.20 x10^6/µl Interval 3.1 to 5.3	3.90 x10^6/µl Interval 2.9 to 5.0	4.10 x10^6/µl Interval 2.9 to 5.8	3.90 x10^6/µl Interval 2.4 to 5.7	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Data Set

Outcome measures

Measure	FS VH S/D 500 S-apr n=70 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=55 Participants Dry gauze pads were positioned to cover the complete study suture line	FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1 n=67 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control: Preop Baseline - Postoperative Day 1 n=57 Participants Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes Leukocytes	7.105 x10^3/µl Interval 2.46 to 14.83	8.260 x10^3/µl Interval 3.85 to 14.16	6.760 x10^3/µl Interval 2.93 to 15.0	7.980 x10^3/µl Interval 3.51 to 13.76	—	—
Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes Basophils	0.040 x10^3/µl Interval 0.0 to 0.11	0.040 x10^3/µl Interval 0.0 to 0.11	0.040 x10^3/µl Interval 0.0 to 0.2	0.050 x10^3/µl Interval 0.0 to 0.16	—	—
Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes Eosinophils	0.180 x10^3/µl Interval 0.0 to 0.96	0.200 x10^3/µl Interval 0.0 to 0.81	0.160 x10^3/µl Interval 0.05 to 0.61	0.220 x10^3/µl Interval 0.0 to 0.79	—	—
Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes Lymphocytes	1.805 x10^3/µl Interval 0.16 to 4.55	1.800 x10^3/µl Interval 0.29 to 3.74	1.700 x10^3/µl Interval 0.54 to 4.61	1.750 x10^3/µl Interval 0.69 to 4.27	—	—
Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes Neutrophils	4.585 x10^3/µl Interval 0.67 to 11.3	5.570 x10^3/µl Interval 2.5 to 11.04	4.560 x10^3/µl Interval 1.32 to 12.19	5.150 x10^3/µl Interval 2.02 to 10.37	—	—
Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes Monocytes	0.370 x10^3/µl Interval 0.09 to 1.02	0.430 x10^3/µl Interval 0.12 to 1.17	0.400 x10^3/µl Interval 0.15 to 0.98	0.460 x10^3/µl Interval 0.13 to 1.09	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Data Set

Outcome measures

Measure	FS VH S/D 500 S-apr n=64 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=52 Participants Dry gauze pads were positioned to cover the complete study suture line	FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1 n=67 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control: Preop Baseline - Postoperative Day 1 n=55 Participants Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Laboratory Values Over Time: Platelets	227.0 x10^3/µl Interval 77.0 to 562.0	303.0 x10^3/µl Interval 92.0 to 643.0	239.0 x10^3/µl Interval 66.0 to 646.0	283.0 x10^3/µl Interval 116.0 to 661.0	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Data Set

Outcome measures

Measure	FS VH S/D 500 S-apr n=70 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=57 Participants Dry gauze pads were positioned to cover the complete study suture line	FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1 n=69 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control: Preop Baseline - Postoperative Day 1 n=57 Participants Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) Creatinine	1.80 mg/dL Interval 0.6 to 13.1	2.20 mg/dL Interval 0.7 to 11.1	2.90 mg/dL Interval 0.4 to 12.4	4.40 mg/dL Interval 0.5 to 10.0	—	—
Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) Bilirubin	0.30 mg/dL Interval 0.2 to 1.2	0.30 mg/dL Interval 0.2 to 1.2	0.30 mg/dL Interval 0.2 to 1.4	0.30 mg/dL Interval 0.2 to 1.3	—	—
Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) BUN	23.0 mg/dL Interval 6.0 to 76.0	23.0 mg/dL Interval 10.0 to 77.0	22.0 mg/dL Interval 7.0 to 111.0	30.0 mg/dL Interval 6.0 to 125.0	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Data Set

Outcome measures

Measure	FS VH S/D 500 S-apr n=69 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=56 Participants Dry gauze pads were positioned to cover the complete study suture line	FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1 n=65 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control: Preop Baseline - Postoperative Day 1 n=57 Participants Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Laboratory Values Over Time: Alanine Aminotransferase (ALT)	16.0 U/L Interval 4.0 to 152.0	16.0 U/L Interval 4.0 to 95.0	14.0 U/L Interval 4.0 to 69.0	13.0 U/L Interval 4.0 to 99.0	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Data Set

Outcome measures

Measure	FS VH S/D 500 S-apr n=58 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=54 Participants Dry gauze pads were positioned to cover the complete study suture line	FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1 n=63 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control: Preop Baseline - Postoperative Day 1 n=56 Participants Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Laboratory Values Over Time: Aspartate Aminotransferase (AST)	21.0 U/L Interval 9.0 to 61.0	20.5 U/L Interval 8.0 to 81.0	19.0 U/L Interval 8.0 to 92.0	20.0 U/L Interval 10.0 to 44.0	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Data Set

Outcome measures

Measure	FS VH S/D 500 S-apr n=65 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=52 Participants Dry gauze pads were positioned to cover the complete study suture line	FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1 n=59 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control: Preop Baseline - Postoperative Day 1 n=53 Participants Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)	24.40 seconds Interval 18.0 to 150.0	25.10 seconds Interval 18.0 to 150.0	25.20 seconds Interval 18.2 to 150.0	25.80 seconds Interval 19.3 to 150.0	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Data Set

Outcome measures

Measure	FS VH S/D 500 S-apr n=66 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control - Manual Compression With Surgical Gauze n=52 Participants Dry gauze pads were positioned to cover the complete study suture line	FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1 n=59 Participants FS VH S/D 500 s-apr was applied to the study suture line	Control: Preop Baseline - Postoperative Day 1 n=53 Participants Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line	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	Control: Preop Baseline - Postoperative Day 14 Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
Laboratory Values Over Time: International Normalized Ratio(INR)	1.00 ratio Interval 0.9 to 3.6	1.00 ratio Interval 0.9 to 4.1	1.00 ratio Interval 0.9 to 1.5	1.00 ratio Interval 0.9 to 4.1	—	—

Adverse Events

FS VH S/D 500 S-apr

Serious events: 20 serious events

Other events: 14 other events

Deaths: 0 deaths

Control - Manual Compression With Surgical Gauze Pads

Serious events: 18 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	FS VH S/D 500 S-apr n=70 participants at risk FS VH S/D 500 s-apr will be applied to the study suture line.	Control - Manual Compression With Surgical Gauze Pads n=70 participants at risk Dry gauze pads will be positioned to cover the complete study suture line.
Cardiac disorders Atrial fibrillation	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Cardiac disorders Cardiac failure congestive	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Gastrointestinal disorders Constipation	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Gastrointestinal disorders Haematemesis	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
General disorders Non-cardiac chest pain	2.9% 2/70 • Number of events 2 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
General disorders Thrombosis in device	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Infections and infestations Appendicitis perforated	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Infections and infestations Staphylococcal sepsis	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Infections and infestations Wound infection staphylococcal	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Injury, poisoning and procedural complications Femoral neck fracture	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Injury, poisoning and procedural complications Postoperative wound infection	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Injury, poisoning and procedural complications Spinal compression fracture	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Injury, poisoning and procedural complications Vascular graft occlusion	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	2.9% 2/70 • Number of events 2 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Injury, poisoning and procedural complications Vascular graft thrombosis	2.9% 2/70 • Number of events 4 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	2.9% 2/70 • Number of events 2 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Metabolism and nutrition disorders Hyponatraemia	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Nervous system disorders Ischaemic neuropathy	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Respiratory, thoracic and mediastinal disorders Respiratory distress	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	2.9% 2/70 • Number of events 2 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Vascular disorders Arterial thrombosis limb	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Vascular disorders Haematoma	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Vascular disorders Steal syndrome	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
General disorders Multi-organ failure	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Infections and infestations Sepsis	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Infections and infestations Urinary tract infection	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Injury, poisoning and procedural complications Drug toxicity	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Injury, poisoning and procedural complications Graft thrombosis	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Injury, poisoning and procedural complications Incision site cellulitis	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Investigations International normalised ratio increased	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	1.4% 1/70 • Number of events 2 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/70 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	1.4% 1/70 • Number of events 1 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.

Other adverse events

Measure	FS VH S/D 500 S-apr n=70 participants at risk FS VH S/D 500 s-apr will be applied to the study suture line.	Control - Manual Compression With Surgical Gauze Pads n=70 participants at risk Dry gauze pads will be positioned to cover the complete study suture line.
General disorders Oedema peripheral	10.0% 7/70 • Number of events 8 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	5.7% 4/70 • Number of events 5 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Injury, poisoning and procedural complications Operative haemorrhage	5.7% 4/70 • Number of events 5 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	1.4% 1/70 • Number of events 2 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Vascular disorders Hypotension	5.7% 4/70 • Number of events 5 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.	2.9% 2/70 • Number of events 3 • Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.

Additional Information

Edith Hantak, Dir, Global Therapeutic Area, BioSurgery

BAXTER INNOVATIONS GmbH

Email: edith_hantak@baxter.com

Results disclosure agreements

• Principal investigator is a sponsor employee Baxter's agreements with PIs may vary per requirements of the individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 1 year after study completion. Baxter requires a review of results communications (e.g., for confidential information) ≥90 days prior to submission or communication. Baxter may request an additional delay of ≤60 days (e.g., for intellectual property protection)
• Publication restrictions are in place

Restriction type: OTHER