Prophylactic effect of cefazolin-vancomycin versus ceftazidime-vancomycin on the infection of surgical site in patients undergoing open heart surgery: a double-blind randomized clinical trial
To assess the prophylactic effect of cefazolin-vancomycin versus ceftazidime-vancomycin on the infection of the surgical site in patients undergoing open-heart surgery
Design
This is a double-blind randomized clinical trial, phase II, in which 434 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients undergoing open-heart surgery will refer to Farshchian Heart Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician will examine the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Indication of open-heart surgery.
Hospitalization for more than three days
Exclusion criteria:
Hemodialysis patients,
History of recurrent Freonocellus,
Having an artificial valve or vascular graft
Intervention groups
Intervention group 1:
Cefazoline injection 2 to 3 g depending on patient's weight every 6 hours and vancomycin injection 15 mg/kg every 12 hours for 48 hours
Intervention group 2:
Ceftazidime injection 1 g every 8 hours and vancomycin injection 15 mg/kg every 12 hours for 48 hours
Main outcome variables
Primary outcome:
Superficial infection at the surgical site
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N324
Registration date:2019-12-17, 1398/09/26
Registration timing:prospective
Last update:2019-12-17, 1398/09/26
Update count:0
Registration date
2019-12-17, 1398/09/26
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-05, 1398/10/15
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic effect of cefazolin-vancomycin versus ceftazidime-vancomycin on the infection of surgical site in patients undergoing open heart surgery: a double-blind randomized clinical trial
Public title
Prophylactic effect of cefazolin-vancomycin versus ceftazidime-vancomycin on the infection of surgical site in patients undergoing open heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Indication of open heart surgery.
Hospitalization for more than three days
Exclusion criteria:
Hemodialysis patients,
History of recurrent Freonocellus,
Having an artificial valve or vascular graft
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
434
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-11-23, 1398/09/02
Ethics committee reference number
IR.UMSHA.REC.1398.689
Health conditions studied
1
Description of health condition studied
Surgical wound infection
ICD-10 code
O86.0
ICD-10 code description
Infection of obstetric surgical wound
Primary outcomes
1
Description
Superficial infection at the surgical site
Timepoint
On days 7, 14, 30 and 90 after surgery
Method of measurement
With clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cefazoline injection 2 to 3 g depending on patient's weight every 6 hours and vancomycin injection 15 mg/kg every 12 hours for 48 hours
Category
Treatment - Drugs
2
Description
Intervention group 2: Ceftazidime injection 1 g every 8 hours and vancomycin injection 15 mg/kg every 12 hours for 48 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Heart Hospital in Hamadan city
Full name of responsible person
Dr Soroor Akbari
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
suak1393@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Soroor Akbari
Position
Infectious Disease Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
suak1393@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Soroor Akbari
Position
Infectious Disease Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
suak1393@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available