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Neptune Pad ® Compared to Conventional Manual Compression

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ClinicalTrials.gov Identifier: NCT00597363
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : January 18, 2008
Information provided by:
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Neptune Pad ® Compared to Conventional Manual Compression for Access Site Management After Peripheral Percutaneous Transluminal Procedures
Study Start Date : January 2006
Primary Completion Date : September 2007
Study Completion Date : January 2008

Arm Intervention/treatment
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.

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597363

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

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
First Posted: January 18, 2008    Key Record Dates
Last Update Posted: January 18, 2008
Last Verified: January 2008

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

Additional relevant MeSH terms:
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications