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.

PURPOSE

To investigate the efficacy and safety of a novel hemostatic wound dressing designed for rapid hemostasis at arterial puncture sites.

METHODS

Over a 15-month period, 209 consecutive patients were randomized to conventional manual compression (n=105) or the use of the Clo-Sur P.A.D. hemostatic device (n=104) after removal of the sheath. Puncture-related and device-related complications, time to hemostasis, time to ambulation, and patient and physician discomfort were recorded.

RESULTS

In 209 patients, 21 (10.0%) puncture-related complications were observed, including 11 (5.3%) pseudoaneurysms, 9 (4.3%) hematomas, and 1 (0.5%) major bleeding complication. There was no significant difference (p=0.36) in complications between the hemostatic device (9/104, 8.7%) and the conventional group (12/105, 11.4%). In the hemostatic device group compared to the conventional group, respectively, the average time to hemostasis (13.6 versus 20.3 minutes; p<0.001), time to ambulation (6.5 versus 17.4 hours, p<0.001), patient discomfort (VAS 2.1 versus 4.7, p<0.001), and physician discomfort (VAS 3.8 versus 5.2, p<0.001) were significantly lower. Twenty (19%) sheath removals in the hemostatic device group were classified as a technical failure of the device.

CONCLUSION

The use of this hemostatic wound dressing for arterial access site management after percutaneous vascular procedures significantly reduced the time to hemostasis, enabled early mobilization, and reduced patient discomfort without increasing the risk for complications compared to conventional manual compression. A high rate of technical failures, however, warrants further improvement before routine use can be recommended.