Comparison of Antibiotic Protocols in Spine Patients With Postoperative Drains

Completed

• Conditions: Surgical Wound Infection; Spinal Degeneration; Spinal Deformity
• Interventions: Other: Antibiotic Protocol

• Registration Number: NCT01608854
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2011-04
• Study Completion: 2012-04
• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-05-31
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-08
• Last Update Posted: 2016-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 539

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Duration Antibiotics	Antibiotic Protocol	Patients were randomized to receive antibiotics for the duration of time a spinal drain was in place following spinal surgery

Primary Outcome Measures

Name	Time	Method
Incidence of Infection	for one year after surgery	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.

Trial Locations

Locations (1)

NYU Hospital for Joint Diseases; 🇺🇸 New York, New York, United States