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Comparison of Antibiotic Protocols in Spine Patients With Postoperative Drains

NYU Langone Health logo

NYU Langone Health

Status

Completed

Conditions

Spinal Degeneration
Spinal Deformity
Surgical Wound Infection

Treatments

Other: Antibiotic Protocol

Study type

Observational

Funder types

Other

Identifiers

NCT01608854
NYUHJD08139

Details and patient eligibility

About

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.

Full 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.

Enrollment

539 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

539 participants in 2 patient groups

24 Hour Antibiotics
Description:
Patients were randomized to receive 24 hours of postoperative antibiotics following spine surgery
Duration Antibiotics
Description:
Patients were randomized to receive antibiotics for the duration of time a spinal drain was in place following spinal surgery
Treatment:
Other: Antibiotic Protocol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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