研究单位:[1]Codman & Shurtleff[2]Los Angeles, California, United States, 90033[3]Gainesville, Florida, United States, 32610[4]Syracuse, New York, United States, 13213[5]Hershey, Pennsylvania, United States, 17033[6]Calgary, Alberta, Canada[7]Edmonton, Alberta, Canada[8]Sherbrooke, Quebec, Canada[9]Tiantan Hospital,Beijing, China[10]Xuan Wu Hospital,Beijing, China[11]Angers, France[12]Lille, France[13]Paris, France, 75013[14]Prince of Wales Hospital,Hong Kong,Hong Kong[15]Queen Mary Hospital,Hong Kong, Hong Kong[16]Oslo, Norway, NO-0027[17]National Neuroscience Institute,Singapore, Singapore[18]Singapore General Hospital,Singapore, Singapore[19]Bristol, United Kingdom, BS 16 1LE[20]Leeds, United Kingdom[21]Salford, United Kingdom
The purpose of this non-significant risk study is to establish initial baseline infection rates for the Codman BACTISEAL External Ventricular Drainage (B-EVD) System (Antibiotic impregnated catheter) and to compare relative rates of ventriculostomy-related infection between Subjects with BACTISEAL or conventional EVD catheters in a prospective, randomized open label study