Neptune Pad ® Compared to Conventional Manual Compression

Not Applicable

Completed

• Conditions: Postoperative Hemorrhage
• Interventions: Other: conventional manual compression; Device: Neptune P.A.D. (R)

• Registration Number: NCT00597363
• Lead Sponsor: Vienna General Hospital

Brief Summary

BACKGROUND. Arterial access site complications remain the most frequent adverse events after percutaneous transluminal procedures. We investigated the safety and efficacy of the pro-coagulant wound dressing Neptune Pad ® compared to conventional manual compression for access site management after peripheral percutaneous interventions.

METHODS. We enrolled 201 consecutive patients and randomly assigned patients for Neptune Pad ® (n=100) vs. conventional manual compression (n=101). Patients were followed clinically until hospital discharge and by duplex ultrasound at 24 hours postprocedure for occurrence of access site complications. Time-to-hemostasis and time-to-ambulation were recorded, patients´ and physicians´ discomfort were measured using a visual analogue scale.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2007-09
• Status Verified: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-01-09
• Study First Submitted QC: 2008-01-17
• Last Update Submitted: 2008-01-17
• Study First Posted: 2008-01-18
• Last Update Posted: 2008-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

• All inguinal punctures (common femoral, superficial femoral and deep femoral artery, antegrade and retrograde access) were included.
• No specific limitations of anti-platelet or anti-coagulant medication were specified.

Exclusion Criteria

• Patients with extreme obesity (BMI above 35 kg/m2) were not included according to the manufactures' recommendations.
• Furthermore, patients with known hypersensitivity to components of the device were not eligible

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	conventional manual compression	manual compression for closure of the vascular access site
1	Neptune P.A.D. (R)	Neptune PAD utilization to accelerate closure of the vascular access site

Trial Locations

Locations (1)

General Hospital Vienna; 🇦🇹 Vienna, Austria