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NCT00530400 Clinical Trial

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

Surgical Wound Infection Clinical Trial

Official title:
Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of Single-Dose Cefuroxime Prophylaxis in Herniated Disk Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00530400
Other study ID # CFX93LS06
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2007
Last updated September 14, 2007
Start date April 1994
Est. completion date March 2000

Study information
Verified date September 2007
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority Switzerland: Institut suisse des produits thérapeutiques
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 1369
Est. completion date March 2000
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• cefuroxime
preoperative intravenous 1.5g cefuroxime
• placebo
preoperative intravenous placebo

Locations
Country Name City State
Switzerland Hôpitaux Universitaire de Genève Geneva
Switzerland Centre Hospitalier Universitaire Vaudois Lausanne

Sponsors (3)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois GlaxoSmithKline, University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of a surgical site infection 6 months
Secondary Occurrence of a post-operative infection other than surgical site infection 6 monts
Secondary Serious adverse event 6 months
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