Neptune Pad ® Compared to Conventional Manual Compression

Vienna General Hospital

Status

Completed

Conditions

Postoperative Hemorrhage

Treatments

Other: conventional manual compression

Device: Neptune P.A.D. (R)

Study type

Interventional

Funder types

Other

Identifiers

NCT00597363

EK 433/2004

Details and patient eligibility

About

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.

Enrollment

201 patients

Sex

All

Volunteers

No 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