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Neptune Pad ® Compared to Conventional Manual Compression

Primary Purpose

Postoperative Hemorrhage

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Neptune P.A.D. (R)

conventional manual compression

About this trial

This is an interventional prevention trial for Postoperative Hemorrhage focused on measuring vascular access site, arterial puncture, femoral pseudoaneurysm

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

General Hospital Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Neptune PAD utilization to accelerate closure of the vascular access site

manual compression for closure of the vascular access site

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00597363

First Posted

January 9, 2008

Last Updated

January 17, 2008

Sponsor

Vienna General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00597363

Brief Title

Neptune Pad ® Compared to Conventional Manual Compression

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

September 2007 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Vienna General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Hemorrhage

Keywords

vascular access site, arterial puncture, femoral pseudoaneurysm

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

201 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Neptune PAD utilization to accelerate closure of the vascular access site

Arm Title

Arm Type

Active Comparator

Arm Description

manual compression for closure of the vascular access site

Intervention Type

Device

Intervention Name(s)

Neptune P.A.D. (R)

Intervention Description

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

Other

Intervention Name(s)

conventional manual compression

Intervention Description

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.

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Schillinger, MD

Organizational Affiliation

Professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

General Hospital Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

16445320

Citation

Mlekusch W, Dick P, Haumer M, Sabeti S, Minar E, Schillinger M. Arterial puncture site management after percutaneous transluminal procedures using a hemostatic wound dressing (Clo-Sur P.A.D.) versus conventional manual compression: a randomized controlled trial. J Endovasc Ther. 2006 Feb;13(1):23-31. doi: 10.1583/05-1679.1.

Results Reference

background

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Neptune Pad ® Compared to Conventional Manual Compression

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