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

Phase 4

Completed

• Conditions: Surgical Wound Infection
• Interventions: Drug: cefuroxime; Drug: placebo

• Registration Number: NCT00530400
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 1994-04
• Study Completion: 2000-03
• Status Verified: 2007-09
• Study First Submitted: 2007-09-13
• Study First Submitted QC: 2007-09-14
• Last Update Submitted: 2007-09-14
• Study First Posted: 2007-09-17
• Last Update Posted: 2007-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1369

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	cefuroxime	intravenous 1.5g cefuroxime
2	placebo	intravenous placebo

Primary Outcome Measures

Name	Time	Method
Occurrence of a surgical site infection	6 months

Secondary Outcome Measures

Name	Time	Method
Occurrence of a post-operative infection other than surgical site infection	6 monts
Serious adverse event	6 months

Trial Locations

Locations (2)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Hôpitaux Universitaire de Genève; 🇨🇭 Geneva, Switzerland