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

This study has been completed.

First Received on September 13, 2007. Last Updated on September 14, 2007 History of Changes

Sponsor:	Centre Hospitalier Universitaire Vaudois
Collaborators:	University Hospital, Geneva GlaxoSmithKline
Information provided by:	Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:	NCT00530400

Purpose

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

Condition	Intervention	Phase
Surgical Wound Infection	Drug: cefuroxime Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of Single-Dose Cefuroxime Prophylaxis in Herniated Disk Surgery

Resource links provided by NLM:

Drug Information available for: Cefuroxime Cefuroxime sodium Cefuroxime axetil

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	1369
Study Start Date:	April 1994
Study Completion Date:	March 2000

Arms	Assigned Interventions
Experimental: 1 intravenous 1.5g cefuroxime	Drug: cefuroxime preoperative intravenous 1.5g cefuroxime
Placebo Comparator: 2 intravenous placebo	Drug: placebo preoperative intravenous placebo

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530400

Locations

Switzerland
Hôpitaux Universitaire de Genève
Geneva, Switzerland, 1211
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011

Sponsors and Collaborators

Centre Hospitalier Universitaire Vaudois

University Hospital, Geneva

GlaxoSmithKline

Investigators

Principal Investigator:

Patrick Francioli, MD

Centre Hospitalier Universitaire Vaudois

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00530400 History of Changes
Other Study ID Numbers:	CFX93LS06
Study First Received:	September 13, 2007
Last Updated:	September 14, 2007
Health Authority:	Switzerland: Institut suisse des produits thérapeutiques

Keywords provided by Centre Hospitalier Universitaire Vaudois:

Antibiotic prophylaxis
Bacterial Infections / prevention & control
Surgical wound infection / prevention & control

Neurosurgery
Postoperative Complications / prevention & control
Clinical trial [publication type]

Additional relevant MeSH terms:

Surgical Wound Infection
Wound Infection
Intervertebral Disk Displacement
Infection
Postoperative Complications
Pathologic Processes
Wounds and Injuries
Spinal Diseases
Bone Diseases

Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical
Cefuroxime
Cefuroxime axetil
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012