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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00530400

Enrollment

1369

Registered

2007-09-17

Start date

1994-04-30

Completion date

2000-03-31

Last updated

2007-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Wound Infection

Keywords

Antibiotic prophylaxis, Bacterial Infections / prevention & control, Surgical wound infection / prevention & control, Neurosurgery, Postoperative Complications / prevention & control, Clinical trial [publication type]

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

Interventions

DRUGcefuroxime

preoperative intravenous 1.5g cefuroxime

DRUGplacebo

preoperative intravenous placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Occurrence of a surgical site infection	6 months

Secondary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026