Study of the Efficacy of Preoperative Cefuroxime Prophylaxis to Prevent Surgical Site Infection in Herniated Disk Surgery
Information source: Centre Hospitalier Universitaire Vaudois
Information obtained from ClinicalTrials.gov on June 20, 2008 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Surgical Wound Infection
Intervention: cefuroxime (Drug); placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Centre Hospitalier Universitaire Vaudois Official(s) and/or principal investigator(s): Patrick Francioli, MD, Principal Investigator, Affiliation: Centre Hospitalier Universitaire Vaudois
Summary
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
Clinical Details
Official title: Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of Single-Dose Cefuroxime Prophylaxis in Herniated Disk Surgery
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Primary outcome: Occurrence of a surgical site infection
Secondary outcome: Occurrence of a post-operative infection other than surgical site infectionSerious adverse event
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Centre Hospitalier Universitaire Vaudois, Lausanne 1011, Switzerland
Hôpitaux Universitaire de Genève, Geneva 1211, Switzerland
Additional Information
Starting date: April 1994
Ending date: March 2000
Last updated: September 14, 2007
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