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Trial record 77 of 530 for:    VANCOMYCIN

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

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ClinicalTrials.gov Identifier: NCT03466645
Recruitment Status : Not yet recruiting
First Posted : March 15, 2018
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Leila Dehghani, Isfahan University of Medical Sciences

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.


Condition or disease Intervention/treatment Phase
Elective Craniotomy-candidated Patients Drug: Vancomycin Drug: Cefazolin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effectiveness of Vancomycin in Comarison With Cefazolin in Prevention of SSI After Craniotomy
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. infection rate [ Time Frame: Until 90 days after admission ]
    compare of infection rate in 2 groups


Secondary Outcome Measures :
  1. length of hospitalization [ Time Frame: Until 90 days after admission ]
    compare the length of hospitalization in 2 groups

  2. raise of ESR & CRP [ Time Frame: Until 90 days after admission ]
    compare the raise of ESR & CRP in 2 groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466645


Contacts
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Contact: Rasool Mohammadi, Student +989365725957 rasool.mohammadi1993@yahoo.com

Locations
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Iran, Islamic Republic of
Isfahan university of medical science. Not yet recruiting
Isfahan, Iran, Islamic Republic of
Contact: Rasool Mohammadi, student    +989365725957    rasool.mohammadi1993@yahoo.com   
Sponsors and Collaborators
Isfahan University of Medical Sciences

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Responsible Party: Leila Dehghani, The effectiveness of vancomycin in comparison with cefazolin in prevention of SSI after craniotomy, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03466645     History of Changes
Other Study ID Numbers: Isfahan University
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leila Dehghani, Isfahan University of Medical Sciences:
SSI
elective Craniotomy
Vancomycin
Cefazolin
Antibiotic
Additional relevant MeSH terms:
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Vancomycin
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents