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

NCT ID: NCT00530400

Last Updated: 2007-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1369 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-04-30

Study Completion Date

2000-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Surgical Wound Infection

Keywords

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Antibiotic prophylaxis Bacterial Infections / prevention & control Surgical wound infection / prevention & control Neurosurgery Postoperative Complications / prevention & control Clinical trial [publication type]

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

intravenous 1.5g cefuroxime

Group Type EXPERIMENTAL

cefuroxime

Intervention Type DRUG

preoperative intravenous 1.5g cefuroxime

2

intravenous placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

preoperative intravenous placebo

Interventions

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cefuroxime

preoperative intravenous 1.5g cefuroxime

Intervention Type DRUG

placebo

preoperative intravenous placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Principal Investigators

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Patrick Francioli, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

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Hôpitaux Universitaire de Genève

Geneva, , Switzerland

Site Status

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CFX93LS06

Identifier Type: -

Identifier Source: org_study_id