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Comparison of Antibiotic Protocols in Spine Patients With Postoperative Drains

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01608854
First received: May 29, 2012
Last updated: June 5, 2012
Last verified: June 2012

May 29, 2012
June 5, 2012
November 2008
April 2011   (final data collection date for primary outcome measure)
Incidence of Infection [ Time Frame: for one year after surgery ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01608854 on ClinicalTrials.gov Archive Site
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Comparison of Antibiotic Protocols in Spine Patients With Postoperative Drains
Prospective, Randomized Study of the Utilization of Antibiotics and Drains in Spinal Surgery

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Surgical spine patients of a single urban institution from 2008-2011

  • Surgical Wound Infection
  • Spinal Deformity
  • Spinal Degeneration
Other: Antibiotic Protocol
Patients were given postoperative antibiotics according to their randomization; antibiotic type and dosage were determined by the attending physician.
  • 24 Hour Antibiotics
    Patients were randomized to receive 24 hours of postoperative antibiotics following spine surgery
  • Duration Antibiotics
    Patients were randomized to receive antibiotics for the duration of time a spinal drain was in place following spinal surgery
    Intervention: Other: Antibiotic Protocol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
539
April 2012
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01608854
NYUHJD08139
No
New York University School of Medicine
New York University School of Medicine
Not Provided
Principal Investigator: Baron S Lonner, MD NYU Hospital for Joint Diseases
New York University School of Medicine
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP