Neptune Pad ® Compared to Conventional Manual Compression

This study has been completed.
Sponsor:
Information provided by:
Vienna General Hospital
ClinicalTrials.gov Identifier:
NCT00597363
First received: January 9, 2008
Last updated: January 17, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention
Postoperative Hemorrhage
Device: Neptune P.A.D. (R)
Other: conventional manual compression

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Neptune Pad ® Compared to Conventional Manual Compression for Access Site Management After Peripheral Percutaneous Transluminal Procedures

Further study details as provided by Vienna General Hospital:

Enrollment: 201
Study Start Date: January 2006
Study Completion Date: January 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Neptune PAD utilization to accelerate closure of the vascular access site
Device: Neptune P.A.D. (R)
The Neptune Pad ® (Biotronik GmbH & Co. KG, Berlin, Germany) is a soft and hydrophilic wound dressing, which has been developed to accelerate local hemostasis, reduce compression times, enable early ambulation and minimize the risk for bleeding complications. Neptune Pad ® consists of calcium alginate, which is cationically charged and exerts potent procoagulant properties.
Active Comparator: 2
manual compression for closure of the vascular access site
Other: conventional manual compression
The most common technique for puncture site management is manual compression. This technique requires an extended pressure on the puncture site, and after achievement of hemostasis a pressure bandage is applied for several hours at bed rest.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00597363

Locations
Austria
General Hospital Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Vienna General Hospital
Investigators
Principal Investigator: Martin Schillinger, MD Professor
  More Information

Publications:
Responsible Party: Prof.Dr. Wolfgang Mlekusch, Department of Internal Medicine, Division of clinical Angiology, MUW Vienna
ClinicalTrials.gov Identifier: NCT00597363     History of Changes
Other Study ID Numbers: EK 433/2004
Study First Received: January 9, 2008
Last Updated: January 17, 2008
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Vienna General Hospital:
vascular access site
arterial puncture
femoral pseudoaneurysm

Additional relevant MeSH terms:
Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications

ClinicalTrials.gov processed this record on August 28, 2014