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

Vaud University Hospital Center

Status and phase: Completed; Phase 4

Conditions: Surgical Wound Infection

Treatments: Drug: placebo; Drug: cefuroxime

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00530400

CFX93LS06

Details and patient eligibility

About

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

Enrollment: 1,369 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,369 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

intravenous 1.5g cefuroxime

Treatment:

Drug: cefuroxime

2

Placebo Comparator group

Description:

intravenous placebo

Treatment:

Drug: placebo