Neptune Pad ® Compared to Conventional Manual Compression
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.
|Postoperative Hemorrhage||Device: Neptune P.A.D. (R) Other: conventional manual compression|
|Study Design:||Allocation: Randomized
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|
|Study Start Date:||January 2006|
|Study Completion Date:||January 2008|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
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: NCT00597363
|General Hospital Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Martin Schillinger, MD||Professor|