Study of the Efficacy of Preoperative Cefuroxime Prophylaxis to Prevent Surgical Site Infection in Herniated Disk Surgery

Verified by: Centre Hospitalier Universitaire Vaudois, September 2007
First Received: September 13, 2007 | Last Updated: September 14, 2007 | Phase: Phase 4 | Start Date: April 1994
Overall Status: Completed | Estimated Enrollment: 1369
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The purpose of the study is to determine whether a single, pre-operative dose of cefuroxime is effective in preventing surgical site infection in patients undergoing surgery for herniated...

Brief Summary

Official Title: “Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of Single-Dose Cefuroxime Prophylaxis in Herniated Disk Surgery”

The purpose of the study is to determine whether a single, pre-operative dose of cefuroxime is effective in preventing surgical site infection in patients undergoing surgery for herniated disk

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Intervention(s) in this Clinical Trial

  • Drug: cefuroxime
    • preoperative intravenous 1.5g cefuroxime
  • Drug: placebo
    • preoperative intravenous placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • intravenous 1.5g cefuroxime
  • Placebo Comparator: 2
    • intravenous placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Occurrence of a surgical site infection
    • Time Frame: 6 months

Secondary Measures

  • Occurrence of a post-operative infection other than surgical site infection
    • Time Frame: 6 monts
  • Serious adverse event
    • Time Frame: 6 months

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Age older than 18
  • spinal surgery for herniated disk

Exclusion Criteria:

  • known or suspected hypersensitivity to cephalosporins
  • type I hypersensitivity to betalactamic antibiotics
  • severe renal function impairment
  • acquired immune deficiency syndrome (AIDS) or other conditions of severe immuno-suppression
  • antibiotic therapy for concomitant infection at the time of surgery
  • pregnancy
  • refusal to participate

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Centre Hospitalier Universitaire Vaudois Other

Overall Clinical Trial Officials and Contacts

Patrick Francioli, MD Principal Investigator Centre Hospitalier Universitaire Vaudois  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00530400

Study ID Number: CFX93LS06

ClinicalTrials.gov Identifier: NCT00530400

Health Authority: Switzerland: Institut suisse des produits thérapeutiques

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