Study of the Efficacy of Preoperative Cefuroxime Prophylaxis to Prevent Surgical Site Infection 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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)


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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

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

Participating 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: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire Vaudois
  • Collaborator
    • University Hospital, Geneva
  • Overall Official(s)
    • Patrick Francioli, MD, Principal Investigator, Centre Hospitalier Universitaire Vaudois

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