- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03466645
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 Contact
- Name: Rasool Mohammadi, student
- Phone Number: +989365725957
- Email: rasool.mohammadi1993@yahoo.com
Study Locations
-
-
-
Isfahan, Iran, Islamic Republic of
- Isfahan university of medical science.
-
Contact:
- Rasool Mohammadi, student
- Phone Number: +989365725957
- Email: rasool.mohammadi1993@yahoo.com
-
-
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
|
The 1st group receives vancomycin an hour before craniotomy
|
Active Comparator: 2nd group, receiving cefazolin
The 2nd group receives cefazolin an hour before craniotomy
|
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.
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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