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...
Date First Received: September 13, 2007
Last Updated: September 14, 2007
Verified by: Centre Hospitalier Universitaire Vaudois, September 2007
Clinical Trial Phase: Phase 4 | Start Date: April 1994
Overall Status: Completed
Estimated Enrollment: 1369
Brief Summary
Official Title: “Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of Single-Dose Cefuroxime Prophylaxis in Herniated Disk Surgery”
Condition Keyword(s):
Intervention(s):
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: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
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
- Time Frame: 6 months
Secondary Measures
- Occurrence of a post-operative infection other than surgical site infection
- Time Frame: 6 monts
- Time Frame: 6 monts
- Serious adverse event
- Time Frame: 6 months
- 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 Sponsor Information
Lead Sponsor: Centre Hospitalier Universitaire Vaudois
Overall Clinical Trial Officials and Contacts
Patrick Francioli, MD Principal Investigator Centre Hospitalier Universitaire Vaudois
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
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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