NCT00530400

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,369

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 1994

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1994

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2000

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2007

Completed
Last Updated

September 17, 2007

Status Verified

September 1, 2007

First QC Date

September 13, 2007

Last Update Submit

September 14, 2007

Conditions

Surgical Wound Infection

Keywords

Antibiotic prophylaxisBacterial Infections / prevention & controlSurgical wound infection / prevention & controlNeurosurgeryPostoperative Complications / prevention & controlClinical trial [publication type]

Outcome Measures

Primary Outcomes (1)

  • Occurrence of a surgical site infection

    6 months

Secondary Outcomes (2)

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

    6 monts

  • Serious adverse event

    6 months

Study Arms (2)

1

EXPERIMENTAL

intravenous 1.5g cefuroxime

Drug: cefuroxime

2

PLACEBO COMPARATOR

intravenous placebo

Drug: placebo

Interventions

cefuroximeDRUG

preoperative intravenous 1.5g cefuroxime

1
placeboDRUG

preoperative intravenous placebo

2

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age older than 18
  • spinal surgery for herniated disk

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpitaux Universitaire de Genève

Geneva, 1211, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Surgical Wound InfectionBacterial InfectionsPostoperative Complications

Interventions

Cefuroxime

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPathologic ProcessesPathological Conditions, Signs and SymptomsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Patrick Francioli, MD

    Centre Hospitalier Universitaire Vaudois

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2007

First Posted

September 17, 2007

Study Start

April 1, 1994

Study Completion

March 1, 2000

Last Updated

September 17, 2007

Record last verified: 2007-09

Locations

CH(2)