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

Tracking Information

First Received Date ^ICMJE

September 13, 2007

Last Updated Date

September 14, 2007

Start Date ^ICMJE

April 1994

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Occurrence of a surgical site infection [ Time Frame: 6 months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00530400 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of Single-Dose Cefuroxime Prophylaxis in Herniated Disk Surgery

Brief 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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Condition ^ICMJE

Surgical Wound Infection

Intervention ^ICMJE

Drug: cefuroxime
Drug: placebo

Study Arms / Comparison Groups

Experimental: intravenous 1.5g cefuroxime
Placebo Comparator: intravenous placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1369

Completion Date

March 2000

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00530400

Responsible Party

Study ID Numbers ^ICMJE

CFX93LS06

Study Sponsor ^ICMJE

Centre Hospitalier Universitaire Vaudois

Collaborators ^ICMJE

University Hospital, Geneva
GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

Patrick Francioli, MD

Centre Hospitalier Universitaire Vaudois

Information Provided By

Centre Hospitalier Universitaire Vaudois

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP