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Comparison of Antibiotic Protocols in Spine Patients With Postoperative Drains

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01608854
First Posted: May 31, 2012
Last Update Posted: June 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
New York University School of Medicine
  Purpose
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.

Condition Intervention
Surgical Wound Infection Spinal Deformity Spinal Degeneration Other: Antibiotic Protocol

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Randomized Study of the Utilization of Antibiotics and Drains in Spinal Surgery

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Incidence of Infection [ Time Frame: 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.


Enrollment: 539
Study Start Date: November 2008
Study Completion Date: April 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other: Antibiotic Protocol
Patients were given postoperative antibiotics according to their randomization; antibiotic type and dosage were determined by the attending physician.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Surgical spine patients of a single urban institution from 2008-2011
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608854


Locations
United States, New York
NYU Hospital for Joint Diseases
New York, New York, United States, 10003
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Baron S Lonner, MD NYU Hospital for Joint Diseases
  More Information

Publications:

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01608854     History of Changes
Other Study ID Numbers: NYUHJD08139
First Submitted: May 29, 2012
First Posted: May 31, 2012
Last Update Posted: June 10, 2016
Last Verified: June 2016

Keywords provided by New York University School of Medicine:
surgical site infection
spinal surgery
prophylactic antibiotics
postoperative spinal drains

Additional relevant MeSH terms:
Wound Infection
Surgical Wound
Surgical Wound Infection
Infection
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents