Neptune Pad ® Compared to Conventional Manual Compression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-01-31

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.

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Detailed Description

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Conditions

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Postoperative Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Neptune PAD utilization to accelerate closure of the vascular access site

Group Type EXPERIMENTAL

Neptune P.A.D. (R)

Intervention Type DEVICE

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.

2

manual compression for closure of the vascular access site

Group Type ACTIVE_COMPARATOR

conventional manual compression

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No