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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 17, 2007
Last Update Posted: September 17, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
University Hospital, Geneva
Information provided by:
Centre Hospitalier Universitaire Vaudois
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:

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


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530400

Hôpitaux Universitaire de Genève
Geneva, Switzerland, 1211
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
University Hospital, Geneva
Principal Investigator: Patrick Francioli, MD Centre Hospitalier Universitaire Vaudois
  More Information

ClinicalTrials.gov Identifier: NCT00530400     History of Changes
Other Study ID Numbers: CFX93LS06
First Submitted: September 13, 2007
First Posted: September 17, 2007
Last Update Posted: September 17, 2007
Last Verified: September 2007

Keywords provided by Centre Hospitalier Universitaire Vaudois:
Antibiotic prophylaxis
Bacterial Infections / prevention & control
Surgical wound infection / prevention & control
Postoperative Complications / prevention & control
Clinical trial [publication type]

Additional relevant MeSH terms:
Communicable Diseases
Wound Infection
Surgical Wound
Surgical Wound Infection
Intervertebral Disc Displacement
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Cefuroxime axetil
Anti-Bacterial Agents
Anti-Infective Agents