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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 1, 2019

Interventions

  • Drug: Vancomycin
    • The 1st group receives vancomycin an hour before craniotomy
  • Drug: Cefazolin
    • The 2nd group receives cefazolin an hour before craniotomy

Arms, Groups and Cohorts

  • Active Comparator: 1st group, receiving 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

Clinical Trial Outcome Measures

Primary Measures

  • infection rate
    • Time Frame: Until 90 days after admission
    • compare of infection rate in 2 groups

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Isfahan University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Leila Dehghani, The effectiveness of vancomycin in comparison with cefazolin in prevention of SSI after craniotomy – Isfahan University of Medical Sciences
  • Overall Contact(s)
    • Rasool Mohammadi, Student, +989365725957, rasool.mohammadi1993@yahoo.com

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