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

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. Identifier: NCT00530400
Recruitment Status : Completed
First Posted : September 17, 2007
Last Update Posted : September 17, 2007
University Hospital, Geneva
Information provided by:
Centre Hospitalier Universitaire Vaudois

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

Condition or disease Intervention/treatment Phase
Surgical Wound Infection Drug: cefuroxime Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1369 participants
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
Study Start Date : April 1994
Actual Study Completion Date : March 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herniated Disk

Arm Intervention/treatment
Experimental: 1
intravenous 1.5g cefuroxime
Drug: cefuroxime
preoperative intravenous 1.5g cefuroxime

Placebo Comparator: 2
intravenous placebo
Drug: placebo
preoperative intravenous placebo

Primary Outcome Measures :
  1. Occurrence of a surgical site infection [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Occurrence of a post-operative infection other than surgical site infection [ Time Frame: 6 monts ]
  2. Serious adverse event [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00530400

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

Layout table for additonal information Identifier: NCT00530400    
Other Study ID Numbers: CFX93LS06
First Posted: September 17, 2007    Key Record Dates
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:
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Communicable Diseases
Wound Infection
Surgical Wound Infection
Intervertebral Disc Displacement
Surgical Wound
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Cefuroxime axetil
Anti-Bacterial Agents
Anti-Infective Agents