Comparison of Antibiotic Protocols in Spine Patients With Postoperative Drains
In spine surgery, postoperative spinal drains are often utilized to prevent fluid buildup around the spinal cord. The purpose of this study is to determine whether postoperative antibiotic treatment continued for the duration of time a drain is in place results in a lower infection rate than antibiotics given for only 24 hours postoperatively.
Surgical Wound Infection
Other: Antibiotic Protocol
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective, Randomized Study of the Utilization of Antibiotics and Drains in Spinal Surgery|
- Incidence of Infection [ Time Frame: for one year after surgery ] [ Designated as safety issue: Yes ]Patients were contacted and their medical records were reviewed for a minimum of one year after surgery in order to determine the incidence of postoperative infection. The Center for Disease Control's definition of surgical site infection was applied in determining infection rates.
|Study Start Date:||November 2008|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
24 Hour Antibiotics
Patients were randomized to receive 24 hours of postoperative antibiotics following spine surgery
Patients were randomized to receive antibiotics for the duration of time a spinal drain was in place following spinal surgery
Other: Antibiotic Protocol
Patients were given postoperative antibiotics according to their randomization; antibiotic type and dosage were determined by the attending physician.
Patients likely to receive postoperative spinal drains were enrolled and randomized preoperatively to receive one of two postoperative antibiotic treatments, either for 24 hours after surgery or for the duration of time the spinal drain was in place. If patients did not receive at least one spinal drain during surgery, they were excluded from the infection analysis and received the institutional standard of 24 hours of postoperative antibiotics. Patients that did receive drains were treated according to their randomization and followed for a minimum of one year for the incidence of surgical site infection. The diagnosis of surgical site infection was determined using the definition provided for the Center for Disease Control (CDC). All patients that developed surgical site infections were treated as appropriate by the attending physician.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608854
|United States, New York|
|NYU Hospital for Joint Diseases|
|New York, New York, United States, 10003|
|Principal Investigator:||Baron S Lonner, MD||NYU Hospital for Joint Diseases|