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

• Sponsor: Isfahan University of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03466645
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 16
• Patients Per Site Per Month: 7.9

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Apr 1, 2018
• Anticipated Primary Completion Date: Apr 1, 2019
• Anticipated Study Completion Date: Aug 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. infection rate [Until 90 days after admission]

   compare of infection rate in 2 groups

Secondary Outcome Measures

1. length of hospitalization [Until 90 days after admission]

   compare the length of hospitalization in 2 groups

2. raise of ESR & CRP [Until 90 days after admission]

   compare the raise of ESR & CRP in 2 groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Isfahan university of medical science.	Isfahan		Iran, Islamic Republic of

Sponsors and Collaborators

• Isfahan University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Other Study ID Numbers: Isfahan University
• First Posted: Mar 15, 2018
• Last Update Posted: Mar 15, 2018
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Leila Dehghani, The effectiveness of vancomycin in comparison with cefazolin in prevention of SSI after craniotomy, Isfahan University of Medical Sciences: SSI; elective Craniotomy; Vancomycin; Cefazolin; Antibiotic
• Additional relevant MeSH terms: Vancomycin; Cefazolin

Study Results

No Results Posted as of Mar 15, 2018