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

Overview

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)

Interventions

  • 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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.