2006
DOI: 10.1007/s00330-006-0279-1
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Postinterventional percutaneous closure of femoral artery access sites using the Clo-Sur PAD device: initial findings

Abstract: The purpose of this study was to evaluate a percutaneous hemostatic device in patients to achieve immediate hemostasis at the vascular access site as well as early ambulation after vascular interventional procedures. In a randomized trial, a hemostatic device (Clo-Sur PAD, Medtronic AVE, Inc., Santa Rosa, CA, USA; n=60) was compared with manual compression (n=60) in patients after endoluminal intervention through an inguinal access (sheath sizes: 5-7 French). Device safety was evaluated by assessing complicati… Show more

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Cited by 25 publications
(19 citation statements)
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“…The procoagulant components of the noninvasive PACDs include, among others, bovine thrombin (D-Stat-Dry-Vascular Solutions), poly-N-acetyl glucosamine derived from marine diatoms (Syvek Patch-Marine Polymer Technologies), polyprolate acetate (Clo-Sur Pad – Scion Cardiovascular) and chitosan obtained from exoskeleton of crustaceans (Chito-Seal, Abbot Vascular, HemCon ® Bandage). Clinical studies of D-Stat-Dry, Syvek Patch, Clor-Sur Pad and Chito-Seal showed that these PACDs applied with compression reduce time to hemostasis after femoral artery catheterization compared with SMC and do not increase the complication rate when using 4–6 F sheaths 8,10,1214…”
Section: Discussionmentioning
confidence: 99%
“…The procoagulant components of the noninvasive PACDs include, among others, bovine thrombin (D-Stat-Dry-Vascular Solutions), poly-N-acetyl glucosamine derived from marine diatoms (Syvek Patch-Marine Polymer Technologies), polyprolate acetate (Clo-Sur Pad – Scion Cardiovascular) and chitosan obtained from exoskeleton of crustaceans (Chito-Seal, Abbot Vascular, HemCon ® Bandage). Clinical studies of D-Stat-Dry, Syvek Patch, Clor-Sur Pad and Chito-Seal showed that these PACDs applied with compression reduce time to hemostasis after femoral artery catheterization compared with SMC and do not increase the complication rate when using 4–6 F sheaths 8,10,1214…”
Section: Discussionmentioning
confidence: 99%
“…Mlekusch et al [9] demonstrated only a minimal reduction in the time to haemostasis, no difference in the time to ambulation and a greater incidence of minor bleeding and complications with the use of a haemostasis pad. Balzer et al [10] demonstrated reduced time for haemostasis and time to ambulation with the use of a haemostasis pad versus conventional MC, but they routinely applied a pressure bandage at the access site for a minimum of 2 h following compression with the haemostasis pad and overall times to haemostasis and required time for application of a pressure bandage (mean 10.15 min and 3.47 h, respectively) remained relatively high in the haemostasis pad group. Small RCTs in the cardiology literature have similarly demonstrated only small reductions in the time required for compression and no significant reduction in the time to ambulation or higher rates of technical failure with haemostasis pads compared to conventional MC [11,12].…”
Section: Non-invasive Adjuncts To Manual Compressionmentioning
confidence: 95%
“…Haemostatic pads are coated with procoagulant material to promote clotting and haemostasis but still require a degree of MC and a period of bedrest. There are two, relatively small, published randomised controlled trials (RCTs) in IR, comparing compression with haemostasis pads and compression with conventional MC [9,10]. Mlekusch et al [9] demonstrated only a minimal reduction in the time to haemostasis, no difference in the time to ambulation and a greater incidence of minor bleeding and complications with the use of a haemostasis pad.…”
Section: Non-invasive Adjuncts To Manual Compressionmentioning
confidence: 98%
“…In-hospital RCTs performed in patients after endovascular procedures 125 , 126 , 127 , 128 , 129 , 130 , 131 , 132 , 133 , 134 , 135 , 136 , 137 demonstrated more rapid bleeding cessation with the use of haemostatic dressings plus direct manual pressure compared with direct manual pressure alone. Many patients in these studies also received anticoagulant medications.…”
Section: First Aidmentioning
confidence: 98%