Neptune Pad ® Compared to Conventional Manual Compression

Postoperative Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597363
• Other study ID #: EK 433/2004
• Status: Completed
• Phase: N/A
• First received: January 9, 2008
• Last updated: January 17, 2008
• Start date: January 2006
• Est. completion date: January 2008

Study information

• Verified date: January 2008
• Source: Vienna General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: January 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postoperative Hemorrhage

Intervention

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.

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.

Locations

Country	Name	City	State
Austria	General Hospital Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna General Hospital

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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. — View Citation