- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00597363
Neptune Pad ® Compared to Conventional Manual Compression
Neptune Pad ® Compared to Conventional Manual Compression for Access Site Management After Peripheral Percutaneous Transluminal Procedures
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Vienna, Austria, 1090
- General Hospital Vienna
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Neptune PAD utilization to accelerate closure of the vascular access site
|
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
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martin Schillinger, MD, Professor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK 433/2004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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