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

Primary Purpose

Surgical Wound Infection

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
cefuroxime
placebo
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Wound Infection focused on measuring Antibiotic prophylaxis, Bacterial Infections / prevention & control, Surgical wound infection / prevention & control, Neurosurgery, Postoperative Complications / prevention & control, Clinical trial [publication type]

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpitaux Universitaire de Genève
  • Centre Hospitalier Universitaire Vaudois

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

intravenous 1.5g cefuroxime

intravenous placebo

Outcomes

Primary Outcome Measures

Occurrence of a surgical site infection

Secondary Outcome Measures

Occurrence of a post-operative infection other than surgical site infection
Serious adverse event

Full Information

First Posted
September 13, 2007
Last Updated
September 14, 2007
Sponsor
Centre Hospitalier Universitaire Vaudois
Collaborators
University Hospital, Geneva, GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00530400
Brief Title
Study of the Efficacy of Preoperative Cefuroxime Prophylaxis to Prevent Surgical Site Infection in Herniated Disk Surgery
Official Title
Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of Single-Dose Cefuroxime Prophylaxis in Herniated Disk Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
April 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2000 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
Collaborators
University Hospital, Geneva, GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
Keywords
Antibiotic prophylaxis, Bacterial Infections / prevention & control, Surgical wound infection / prevention & control, Neurosurgery, Postoperative Complications / prevention & control, Clinical trial [publication type]

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1369 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
intravenous 1.5g cefuroxime
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
intravenous placebo
Intervention Type
Drug
Intervention Name(s)
cefuroxime
Intervention Description
preoperative intravenous 1.5g cefuroxime
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
preoperative intravenous placebo
Primary Outcome Measure Information:
Title
Occurrence of a surgical site infection
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Occurrence of a post-operative infection other than surgical site infection
Time Frame
6 monts
Title
Serious adverse event
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Francioli, MD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Universitaire de Genève
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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