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| Sponsored by: |
Vienna General Hospital |
| Information provided by: | Vienna General Hospital |
| ClinicalTrials.gov Identifier: | NCT00597363 |
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 |
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Postoperative Hemorrhage |
Device: Neptune P.A.D. (R) Other: conventional manual compression |
| ChemIDplus related topics: | Calcium gluconate Alginic acid |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Neptune Pad ® Compared to Conventional Manual Compression for Access Site Management After Peripheral Percutaneous Transluminal Procedures |
| 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 |
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1: Experimental
Neptune PAD utilization to accelerate closure of the vascular access site
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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.
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2: Active Comparator
manual compression for closure of the vascular access site
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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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Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Department of Internal Medicine, Division of clinical Angiology, MUW Vienna ( Prof.Dr. Wolfgang Mlekusch ) |
| Study ID Numbers: | EK 433/2004 |
| First Received: | January 9, 2008 |
| Last Updated: | January 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00597363 |
| Health Authority: | Austria: Agency for Health and Food Safety |
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