Neptune Pad ® Compared to Conventional Manual Compression

Study Overview
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Brief Summary
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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.

Official Title
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Neptune Pad ® Compared to Conventional Manual Compression for Access Site Management After Peripheral Percutaneous Transluminal Procedures

Conditions
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Postoperative Hemorrhage

Intervention / Treatment
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* Device: Neptune P.A.D. (R)
* Other: conventional manual compression


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Neptune PAD utilization to accelerate closure of the vascular access site | Device: Neptune P.A.D. (R)<br>* 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.<br>|
| Active Comparator: 2<br>manual compression for closure of the vascular access site | Other: conventional manual compression<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vascular access site, arterial puncture, femoral pseudoaneurysm