Comparison of Antibiotic Protocols in Spine Patients With Postoperative Drains

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective, Randomized Study of the Utilization of Antibiotics and Drains in Spinal Surgery

Conditions
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Surgical Wound Infection, Spinal Deformity, Spinal Degeneration

Intervention / Treatment
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* Other: Antibiotic Protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 24 Hour Antibiotics<br>Patients were randomized to receive 24 hours of postoperative antibiotics following spine surgery | |
| Duration Antibiotics<br>Patients were randomized to receive antibiotics for the duration of time a spinal drain was in place following spinal surgery | Other: Antibiotic Protocol<br>* Patients were given postoperative antibiotics according to their randomization; antibiotic type and dosage were determined by the attending physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Infection | 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. | for one year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical site infection, spinal surgery, prophylactic antibiotics, postoperative spinal drains