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Neptune Pad ® Compared to Conventional Manual Compression

NCT00597363 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2008-01-18

No results posted yet for this study

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.

Conditions

  • Postoperative Hemorrhage

Interventions

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.

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.

Sponsors & Collaborators

  • Vienna General Hospital

    lead OTHER

Principal Investigators

  • Martin Schillinger, MD · Professor

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2007-09-30
Completion
2008-01-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00597363 on ClinicalTrials.gov