Clinical trial NCT01608854: Comparison of Antibiotic Protocols in Spine Patients With Postoperative Drains
Official title: Prospective, Randomized Study of the Utilization of Antibiotics and Drains in Spinal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Wound Infection
Spinal Deformity
Spinal Degeneration
Keywords: surgical site infection
spinal surgery
prophylactic antibiotics
postoperative spinal drains
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 539
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Surgical spine patients of a single urban institution from 2008-2011

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Must be scheduled to undergo spine surgery with likely drain placement (3 or more vertebral levels, dependent upon attending surgeon)
* Must be over the age of 18
* Must consent to randomized postoperative antibiotic treatment

Exclusion Criteria:

* Does not receive a drain at the time of surgery
* Surgery is cancelled
* Infection is present at the time of initial surgery

Primary outcomes:
measure: Incidence of Infection
timeFrame: for one year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Hospital for Joint Diseases
state: New York
Study officials:
affiliation: NYU Hospital for Joint Diseases
name: Baron S Lonner, MD
role: PRINCIPAL_INVESTIGATOR
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