Neptune Pad ® Compared to Conventional Manual Compression
|ClinicalTrials.gov Identifier: NCT00597363|
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : January 18, 2008
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||Phase|
|Postoperative Hemorrhage||Device: Neptune P.A.D. (R) Other: conventional manual compression||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||201 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neptune Pad ® Compared to Conventional Manual Compression for Access Site Management After Peripheral Percutaneous Transluminal Procedures|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||January 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597363
|General Hospital Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Martin Schillinger, MD||Professor|