Skip to content

Comparison of Antibiotic Protocols in Spine Patients With Postoperative Drains

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01608854
Enrollment
539
Registered
2012-05-31
Start date
2008-11-30
Completion date
2012-04-30
Last updated
2016-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Deformity, Spinal Degeneration, Surgical Wound Infection

Keywords

surgical site infection, spinal surgery, prophylactic antibiotics, postoperative spinal drains

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.

Interventions

OTHERAntibiotic Protocol

Patients were given postoperative antibiotics according to their randomization; antibiotic type and dosage were determined by the attending physician.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Infectionfor one year after surgeryPatients 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026