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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.
Sponsor:
Collaborators:
University Hospital, Geneva
GlaxoSmithKline
Information provided by:
Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT00530400
First received: September 13, 2007
Last updated: September 14, 2007
Last verified: September 2007
History of Changes
  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 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:

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 June 18, 2013