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OpenTrials
Completed

NCT Number: NCT00530400

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

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

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Key information

Conditions

Surgical Wound Infection Bacterial Infections Bacterial Infections and Mycoses Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Wound Infection

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpitaux Universitaire de Genève, Geneva, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cefuroxime

Drug

preoperative intravenous 1.5g cefuroxime

Placebo

Drug

preoperative intravenous placebo

Primary outcomes

  1. Occurrence of a surgical site infection

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 monts

  2. Serious adverse event

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Collaborators

  • GlaxoSmithKline
  • University Hospital, Geneva

Registry information

Official study title

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

Important dates

Study start
1994
Study completion
2000
First posted
Sep 17, 2007
Registry last updated
Sep 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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