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

Condition(s) targeted: Surgical Wound Infection

Intervention: cefuroxime (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Centre Hospitalier Universitaire Vaudois

Official(s) and/or principal investigator(s):
Patrick Francioli, MD, Principal Investigator, Affiliation: Centre Hospitalier Universitaire Vaudois

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

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

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Primary outcome: Occurrence of a surgical site infection

Secondary outcome:

Occurrence of a post-operative infection other than surgical site infection

Serious adverse event

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

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

Centre Hospitalier Universitaire Vaudois, Lausanne 1011, Switzerland

Hôpitaux Universitaire de Genève, Geneva 1211, Switzerland

Starting date: April 1994
Ending date: March 2000
Last updated: September 14, 2007