title: Hemostatic Wound Dressing for Postinterventional Hemostasis in Large Femoral Artery Access Sites: An Initial Efficacy and Safety Study.
abstract: To present the results of a prospective single-center study that evaluated the safety and efficacy of a hemostatic dressing following femoral artery access.
  
  
  
  Within a 9-month period, 80 patients (mean age 68±14 years; 55 men) were treated with a hemostatic dressing patch (Hematrix Active Patch) containing aminocaproic acid, calcium chloride, and thrombin after endovascular procedures via a 6- to 8-F femoral artery access. After removing the sheath, the wound dressing was placed on the puncture site followed by constant manual compression adapted to the sheath size (specified pressure times: 8 minutes for 6-F, 9 minutes for 7-F, and 10 minutes for 8-F). Patients were treated with an additional pressure bandage for 24 hours. Hemostasis was checked clinically and with duplex ultrasound after patch removal and at 24 hours. Patient characteristics [platelets, systolic blood pressure, international normalized ratio (INR), and partial thromboplastin time (PTT)], sheath sizes, and approach direction were compared among patients with successful hemostasis (within specified pressure times) vs those with prolonged compression.
  
  
  
  A total of 39 6-F, 19 7-F, and 22 8-F sheaths were employed. In 73 (91.2%) of 80 patients, hemostasis was reached within the prespecified pressure times (mean 8.8±0.8 minutes). In 7 patients (4 6-F, 1 7-F, 2 8-F) a longer compression time was necessary (mean 34±30 minutes). No serious major complication occurred. Twelve (15.0%) minor and 5 (6.3%) moderate subcutaneous hematomas were observed. Two (2.5%) false aneurysms were treated successfully. Ambulation and discharge was possible within 24 hours in 79 (98.7%) cases. Patients with initial hemostasis and those with prolonged compression did not differ substantially (p>0.05) according to sheath size, approach direction, INR (1.09±0.3 vs 1.11±0.3), platelets (234±47×10(3)/µL vs 249±93×10(3)/µL), systolic blood pressure (150±26 vs 152±17 mm Hg), or PTT (31±7.9 vs 34.8±10.0 seconds).
  
  
  
  The evaluated wound dressing seems to be safe and effective in reducing time to hemostasis in large arterial access sites. However, a randomized trial with a larger population and an active control group is necessary to confirm these preliminary data. Moreover, additional focus on shortening the time to ambulation is required in future studies.
authors.affiliation: Department for Diagnostic and Interventional Radiology, University Hospital Wuerzburg, Germany sauer_a4@ukw.de.
authors.forename: Alexander
authors.initials: A
authors.lastname: Sauer
authors.affiliation: Department for Diagnostic and Interventional Radiology, University Hospital Wuerzburg, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Dierks
authors.affiliation: Department for Diagnostic and Interventional Radiology, University Hospital Wuerzburg, Germany.
authors.forename: Franziska
authors.initials: F
authors.lastname: Wolfschmidt
authors.affiliation: Department for Diagnostic and Interventional Radiology, University Hospital Wuerzburg, Germany.
authors.forename: Nicole
authors.initials: N
authors.lastname: Hassold
authors.affiliation: Department for Diagnostic and Interventional Radiology, University Hospital Wuerzburg, Germany.
authors.forename: Thorsten A
authors.initials: TA
authors.lastname: Bley
authors.affiliation: Department for Diagnostic and Interventional Radiology, University Hospital Wuerzburg, Germany.
authors.forename: Ralph
authors.initials: R
authors.lastname: Kickuth
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015119:Aminocaproic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D001458:Bandages; D001780:Blood Coagulation Tests; D002122:Calcium Chloride / Q000008:administration & dosage* / Q000009:adverse effects; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000295:instrumentation; D005260:Female; D005263:Femoral Artery; D005858:Germany; D006470:Hemorrhage / Q000097:blood / Q000209:etiology / Q000517:prevention & control*; D006487:Hemostasis / Q000187:drug effects*; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation*; D006490:Hemostatics / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D011312:Pressure; D011446:Prospective Studies; D011677:Punctures; D013917:Thrombin / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices
chemical_list: D006490:Hemostatics; D013917:Thrombin; D002122:Calcium Chloride; D015119:Aminocaproic Acid
keywords: compression; femoral artery access; hematoma; hemostasis; hemostatic dressing patch; pseudoaneurysm; vascular access