The Effectiveness of Vancomycin in Comarison With Cefazol... | NCT03466645

Studies
The Effectiveness of Vancomycin in Comarison With Cefazolin in Prevention of SSI After Craniotomy

NCT03466645

Sponsor

Isfahan University of Medical Sciences

Status

Unknown status

Last Update Posted

Mar 15, 2018Actual

Enrollment

126Estimated

Phase

Phase 1Phase 2

Conditions

Elective Craniotomy-candidated Patients

Interventions

Vancomycin
Cefazolin

Countries

Iran

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

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2018Estimated

Primary Completion Date

Apr 1, 2019Estimated

Completion Date

Aug 1, 2019Estimated

First Submitted Date

Mar 9, 2018

First Submission Date that Met QC Criteria

Mar 9, 2018

First Posted Date

Mar 15, 2018Actual

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

Mar 9, 2018

Last Update Posted Date

Mar 15, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leila Dehghani, The effectiveness of vancomycin in comparison with cefazolin in prevention of SSI after craniotomy, Isfahan University of Medical SciencesPrincipal Investigator

Lead Sponsor

Isfahan University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Surgical-site infection is the most commonly reported nosocomial infection in patients undergoing surgery and 3rd most nosocomial infection in hospitalized patients. The SSI is associated with increases of length of hospitalization for 6 days and increases the hospital's cost by $ 300.

Because of these, prevention of SSI with appropriate antibiotic is essential.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

126Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1st group, receiving vancomycin	Active Comparator	The 1st group receives vancomycin an hour before craniotomy	Drug: Vancomycin
2nd group, receiving cefazolin	Active Comparator	The 2nd group receives cefazolin an hour before craniotomy	Drug: Cefazolin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vancomycin	Drug	The 1st group receives vancomycin an hour before craniotomy	1st group, receiving vancomycin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
infection rate	compare of infection rate in 2 groups	Until 90 days after admission

Secondary Outcomes

Measure	Description	Time Frame
length of hospitalization	compare the length of hospitalization in 2 groups	Until 90 days after admission
raise of ESR & CRP	compare the raise of ESR & CRP in 2 groups

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18 years and above
elective surgical patients
No pre-surgery infection
Do not use antibiotics before surgery
Insensitivity to beta-lactam antibiotics

Exclusion Criteria:

cranioplasty
Failure to follow the patient
The patient's unwillingness to continue participating in the research project
Death of the patient

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rasool Mohammadi, Student	Contact	+989365725957		rasool.mohammadi1993@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Isfahan university of medical science.		Isfahan			Iran

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014640	Vancomycin
D002437	Cefazolin

Ancestor Terms

ID	Term
D006020	Glycopeptides
D006001	Glycoconjugates
D002241	Carbohydrates
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided