Clinical randomized study to evaluate the effect of using a hydrophobically modified polysaccharide (hm-P) bandage
The study will evaluate the clinical performance (e.g. hemostatic and patient outcomes) of this hm-P bandage by using an earlier time for removal of the bandage (e.g. 60 minutes) than the current standard of care (e.g. 90-180 minutes) while also reducing the inflated pressure of the band, and hence the compressive force put on the wrist of the patient, in increments of the % of inflation as per current protocol, with N=20 @ 100%, N=20 @ 75%, \& N=20 @ 50%. This study will be completed while maintaining vascular integrity and patency through visualization in patients undergoing angiographic procedures via anticoagulated, percutaneous radial arterial cannulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
hm-P bandage will be placed over the puncture site with the TR band positioned over the hemostatic bandage. The TR band will then be inflated per device specific instructions and to the group instructions. The arterial sheath will be removed from the body with slight device rotation.
Lenox Hill Hospital - Northwell Health
New York, New York, United States
Time to hemostasis
Significant change in time to hemostasis
Time frame: 60 minutes
Compressive Force
Change in the compressive force onto the access site
Time frame: 60 minutes
Radial Artery
Evaluation of the radial artery post hemostasis by visual or reverse Barbeau test
Time frame: immediately after hemostasis
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