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

This study has been completed.
University Hospital, Geneva
Information provided by:
Centre Hospitalier Universitaire Vaudois Identifier:
First received: September 13, 2007
Last updated: September 14, 2007
Last verified: September 2007

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: 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:

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


Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its identifier: 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

No publications provided 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
Postoperative Complications / prevention & control
Clinical trial [publication type]

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Intervertebral Disk Displacement
Postoperative Complications
Pathologic Processes
Wounds and Injuries
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Cefuroxime axetil
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 17, 2014