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Neptune Pad ® Compared to Conventional Manual Compression
This study has been completed.
Study NCT00597363   Information provided by Vienna General Hospital
First Received: January 9, 2008   Last Updated: January 17, 2008   History of Changes

January 9, 2008
January 17, 2008
January 2006
September 2007   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00597363 on ClinicalTrials.gov Archive Site
 
 
 
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.

 
 
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Postoperative Hemorrhage
  • Device: Neptune P.A.D. (R)
  • Other: conventional manual compression
  • Experimental: Neptune PAD utilization to accelerate closure of the vascular access site
  • Active Comparator: manual compression for closure of the vascular access site
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
201
January 2008
September 2007   (final data collection date for primary outcome measure)

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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00597363
Prof.Dr. Wolfgang Mlekusch, Department of Internal Medicine, Division of clinical Angiology, MUW Vienna
EK 433/2004
Vienna General Hospital
 
Principal Investigator: Martin Schillinger, MD Professor
Vienna General Hospital
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP