Neptune Pad ® Compared to Conventional Manual Compression
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
|---|---|
|
Postoperative Hemorrhage |
Device: Neptune P.A.D. (R) Other: conventional manual compression |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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 |
| 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 |
|---|---|
|
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.
|
Eligibility| Genders Eligible for Study: | Both |
| 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
Contacts and Locations More Information
Publications:
| 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 |
| Study First Received: | January 9, 2008 |
| Last Updated: | January 17, 2008 |
| Health Authority: | Austria: Agency for Health and Food Safety |
Keywords provided by Vienna General Hospital:
|
vascular access site arterial puncture femoral pseudoaneurysm |
Additional relevant MeSH terms:
|
Hemorrhage Postoperative Hemorrhage Pathologic Processes Postoperative Complications |
ClinicalTrials.gov processed this record on May 21, 2013