Collagen application for sealing of arterial puncture sites in comparison to pressure dressing: A randomized trial

Abstract

One hundred patients undergoing routine diagnostic or interventional catheterization were randomly assigned to receive either percutaneously applied collagen (group A; n = 50) or conventional pressure dressing (group B; n = 50) for sealing of the femoral artery. Clinical variables were comparable in both groups. The heparin dose was 100 IU/kg in 30 patients and 200 IU/kg in 20 patients of either group. The average compression time was 4.3 min in group A and 42.3 min in group B (p < .001). Bleeding was not observed in group A but was observed in 6/50 patients in group B. The time to ambulation was 6.4 hr (range, 4-12 hr) in group A and 21.6 hr (range, 10-48 hr) in group B (p < .001). Hematomas with a diameter of > 6 cm developed in 4/50 patients in group A and in 11/50 patients in group B (p < .05). Blood-transfusions or surgical interventions were not required and there was no loss of ankle pulses in either group. In conclusion, percutaneously applied collagen reduced compression time and duration of bedrest after diagnostic catheterization and PTCA. Despite earlier ambulation, the incidence of bleeding was lower with collagen than with conventional pressure dressing.

Arteriotomy Closure Devices for Cardiovascular Procedures

“…It was originally studied in a cohort of 100 patients undergoing diagnostic or interventional catheterization procedures and randomized to the device or to conventional pressure dressing. 50 Use of the Vasoseal resulted in a shorter compression time (4 versus 42 minutes, PϽ0.001) and faster ambulation (6 versus 22 hours, PϽ0.001) and demonstrated a trend toward a reduction in bleeding rates. 50 -52 The efficacy of the Vasoseal was subsequently confirmed in other randomized studies, 53,54 although other trials showed small increases in access-site complications or failed to demonstrate superiority over mechanical compression during PCI.…”

Sheath pulling immediately after PTCA: Comparison of two different deployment techniques for the hemostatic puncture closure device: A prospective, randomized study

“…The size of hematoma/ecchymosis was measured before ambulation by planimetry and expressed in cm 2 .…”

“…With the development of new sealing devices for closing femoral arterial puncture sites, immediate sheath pulling in anticoagulated patients with a low risk of bleeding complications became reality [1][2][3][4][5][6][7][8]. Whereas the administration of the vascular hemostatic device (VHD) on the surface of the arterial puncture site [9] as well as the application of a suture-mediated closure device [10] are straightforward (using deployment techniques with standardized application protocols), the use of the hemostatic puncture closing device (HPCD) [11] allows several possibilities regarding its deployment time (DT): the recommended DT of 30 minutes [11] leads to a prolonged stay in the catheterization laboratory facilities, slowing down the transfer of the patients to the intermediate care unit.…”

Reduction of femoral artery bleeding post catheterization using a collagen enhanced fibrin sealant

“…Collagen has a long history of surgical use for its hemostatic properties [16][17][18]. For this application, several different collagen plug devices have been developed and investigated in extensive laboratory and clinical trials over the past several years [19][20][21][22][23][24][25][26][27][28][29][30]. More recently, the application of fibrin sealant has been considered as a method for sealing arterial puncture sites.…”