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
  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 ] [ 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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 29, 2012
Last Updated: June 5, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Congenital Abnormalities
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Wounds and Injuries
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 22, 2014