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

I

Isfahan University of Medical Sciences

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Elective Craniotomy-candidated Patients

Treatments

Drug: Cefazolin
Drug: Vancomycin

Study type

Interventional

Funder types

Other

Identifiers

NCT03466645
Isfahan University

Details and patient eligibility

About

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.

Enrollment

126 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

126 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Rasool Mohammadi, Student

Data sourced from clinicaltrials.gov

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