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

March 9, 2018 updated by: Leila Dehghani, Isfahan University of Medical Sciences

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1st group, receiving vancomycin
The 1st group receives vancomycin an hour before craniotomy
Drug: Vancomycin
The 1st group receives vancomycin an hour before craniotomy
Active Comparator: 2nd group, receiving cefazolin
The 2nd group receives cefazolin an hour before craniotomy
Drug: Cefazolin
The 2nd group receives cefazolin an hour before craniotomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2018

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

March 9, 2018

First Submitted That Met QC Criteria

March 9, 2018

First Posted (Actual)

March 15, 2018

Study Record Updates

Last Update Posted (Actual)

March 15, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Isfahan University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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