Study of the Efficacy of Preoperative Cefuroxime Prophyla... | NCT00530400

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

NCT00530400

Sponsor

Centre Hospitalier Universitaire Vaudois

Status

Completed

Last Update Posted

Sep 17, 2007Estimated

Enrollment

1,369Actual

Phase

Phase 4

Conditions

Surgical Wound Infection

Interventions

cefuroxime
placebo

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1994

Primary Completion Date

Not provided

Completion Date

Mar 2000Actual

First Submitted Date

Sep 13, 2007

First Submission Date that Met QC Criteria

Sep 14, 2007

First Posted Date

Sep 17, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2007

Last Update Posted Date

Sep 17, 2007Estimated

Name	Class
University Hospital, Geneva	OTHER
GlaxoSmithKline	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,369Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	intravenous 1.5g cefuroxime	Drug: cefuroxime
2	Placebo Comparator	intravenous placebo	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cefuroxime	Drug	preoperative intravenous 1.5g cefuroxime	1
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of a surgical site infection		6 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick Francioli, MD	Centre Hospitalier Universitaire Vaudois	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpitaux Universitaire de Genève		Geneva		1211	Switzerland
Centre Hospitalier Universitaire Vaudois

Condition Browse Module

MeSH Terms

ID	Term
D013530	Surgical Wound Infection
D001424	Bacterial Infections
D011183	Postoperative Complications

Ancestor Terms

ID	Term
D014946	Wound Infection
D007239	Infections
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002444	Cefuroxime

Ancestor Terms

ID	Term
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930

Browse Leaves

Not provided

Browse Branches

Not provided