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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03466645
Other study ID # Isfahan University
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received March 9, 2018
Last updated March 9, 2018
Start date April 1, 2018
Est. completion date August 1, 2019

Study information

Verified date December 2017
Source Isfahan University of Medical Sciences
Contact Rasool Mohammadi, Student
Phone +989365725957
Email rasool.mohammadi1993@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 126
Est. completion date August 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Elective Craniotomy-candidated Patients

Intervention

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

Locations

Country Name City State
Iran, Islamic Republic of Isfahan university of medical science. Isfahan

Sponsors (1)

Lead Sponsor Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary infection rate compare of infection rate in 2 groups Until 90 days after admission
Secondary length of hospitalization compare the length of hospitalization in 2 groups Until 90 days after admission
Secondary raise of ESR & CRP compare the raise of ESR & CRP in 2 groups Until 90 days after admission