The aim of current study was to compare the efficacy of the two different prophylactic antibiotic regiments (i.e. 2 days vs 7 days period) in prevention of surgical site infection. Current study was done by enrolling 370 patients aged 18-80 years old who underwent the coronary artery bypass surgery. Enrolled Patients were divided into two groups randomly. Randomization was performed by random number generator software (V 1/3). As a double blind study, not only surgeons but also patients weren’t aware of the applied regiments, and there was a third person who was responsible for drug prescription in the study. In both groups, before the operation, 2gr of cefazolin was injected intravenously during the induction of anesthesia and continued with dose of 1gr every 6 hours. Then, group 1 received cephalexin capsule (i.e. 500mg) every 6 hours for 5 days, and group 2 (as a placebo group) received placebo every 6 hours for 5 days. Patients were followed for 3 months. Daily care of the wound was done by patients themselves who were trained about the surgical site infection. When they encountered the signs of inflammation (e.g. redness, warmth, pain, and wound secretion) they were referred to doctor. Thereafter the sample of secretion was sent to the laboratory for culture and antibiogram.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201707188968N2
Registration date:2017-11-08, 1396/08/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-08, 1396/08/17
Registrant information
Name
Mostafa Javanian
Name of organization / entity
Babol University of Medical Sciences-Tropical And Infectious diseases research center
Country
Iran (Islamic Republic of)
Phone
+98 11 1219 0624
Email address
m.javanian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Babol University of Medical Sciences
Expected recruitment start date
2017-07-16, 1396/04/25
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing two and seven days antibiotic prophylaxis in prevention of surgical site infection in coronary artery bypass surgery
Public title
Antibiotic prophylaxis in prevention of surgical site infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : All patients with indication of CABG
Exclusion criteria : Patients > 80 and < 18 years old; ejection fraction <35%; history of hypersensitivity to antibiotics; cardiac surgery other than CABG (such as replacing cardiac valves); Presence of infection and recent antibiotic use; immunocompromised patients; repetition of surgery at the same site; Patients on mechanical ventilation more than 24 hours or stayed more than 3 days in ICU ; On-pump heart surgery; more than 6 units Blood transfusion; duration of surgery > 6 hours or duration of Pomp time more >120 minutes or aorta clumping time > 60 minutes; insertion of intra aortic ballon pupm; use high dose of inotropes; Emergent surgery; The presence of Comorbidities (e.g. liver failure , renal failure (serum cratinine > 2).
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
370
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization performed by Random Number Generator software
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Science
Street address
Babol Ayatolah Rouhani Hospital, Ganjafrooz Street
City
Babol
Postal code
Approval date
2017-07-16, 1396/04/25
Ethics committee reference number
MUBABOL.HRI.REC.1396.10
Health conditions studied
1
Description of health condition studied
Surgical Site Infection
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Infection rate
Timepoint
48h after the surgery, 7-10 days after the surgery, 30 days after the surgery
Method of measurement
Wound observation
Secondary outcomes
1
Description
Responsible pathogens for infection
Timepoint
-
Method of measurement
Wound secretion culture
2
Description
Drug resistance
Timepoint
-
Method of measurement
Antibiogram
Intervention groups
1
Description
Intervention group 1: Received amp cefazolin 1 gr Iv q 6 hours for 48 h and then cap cephalexin 500 mg q 6 hours for 5 days (Farabi pharmaceutical company).
Category
Treatment - Drugs
2
Description
Intervention group 2: Received amp cefazolin 1 gr Iv q 6 hours for 48 h and then placebo q 6 hours for 5 days (Farabi pharmaceutical company).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Ayatolah Rouhani Hospital
Full name of responsible person
Mostafa Javanian
Street address
Babol Ayatolah Rouhani Hospital, Ganjafrooz Street
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor Of Research Babol University Of Medical Sciences
Full name of responsible person
Mostafa Javanian
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor Of Research Babol University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Mostafa Javanian
Position
Associate professor of infectious and tropical diseases
Other areas of specialty/work
Street address
Infectious and tropical diseases Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 3223 8301
Fax
Email
m.javanian@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babaol University Of Medical Sciences
Full name of responsible person
Mosatafa Javanian
Position
associate professor of infectious and tropical diseases
Other areas of specialty/work
Street address
infectious and tropical diseases Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 3223 8301
Fax
Email
m.javanian@mubabol.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babaol University Of Medical Sciences
Full name of responsible person
Zahra Aliramaji
Position
Resident in training of infectious and tropical diseases
Other areas of specialty/work
Street address
infectious and tropical diseases Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 3223 8301
Fax
Email
zahraaliramaji@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)