Determining the role of antibiotics in prevention of wound infections in the surgical site of arteriovenous fistula surgery in dialysis patients
Design
Clinical trial with control group, Randomised, parallel group trial without blinded outcome assessment
Settings and conduct
The sample included dialysis patients who will undergo surgery for insertion of arteriovenous fistula in Imam Reza Hospital of Tabriz.60 patients who will be embedde with an arteriovenous fistula will be randomly selected and 20 will receive only one pre-operative antibiotic dose, 20 will be given a preoperative dose and will continue for up to 20 days, and 20 others Antibiotics will not be given and the results of the examination of the scar tissue infection will be compared between the two groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients requiring fistula surgery;Surgery is done by an attending surgeon
Exclusion criteria: No consent to enter the study; Use of Immunosuppressant drugs or Chemotherapy; Active infection anywhere in the body; Prohibition of antibiotic use for any reason
Intervention groups
60 patients who will be embedde with an arteriovenous fistula will be randomly selected and 20 will receive only one pre-operative antibiotic dose, 20 will be given a preoperative dose and will continue for up to 20 days, and 20 others Antibiotics will not be given and the results of the examination of the scar tissue infection will be compared between the two groups.
Main outcome variables
Surgical site infection; type of surgery; pulmonary infection; urinary tract infection; sepsis; mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140203016473N10
Registration date:2018-06-21, 1397/03/31
Registration timing:prospective
Last update:2018-06-21, 1397/03/31
Update count:0
Registration date
2018-06-21, 1397/03/31
Registrant information
Name
Farzad Kakaei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 1317
Email address
fkakaei@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-21, 1397/04/30
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of Antibiotic in the prevention of surgical site infection after hemodialysis access surgery
Public title
The role of Antibiotic in the prevention of surgical site infection after hemodialysis access surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients requiring fistula surgery
surgery is done by an attending surgeon
Exclusion criteria:
Patients who are currently in need of transplant or chemotherapy
Patients who need antibiotics because of an active infection anywhere in the body, such as pneumonia or diabetic foot
Patients who have been Impaired for any reason during their sterile action
Patients who are forbidden to antibiotic use for any reason, such as allergy history
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sixty patients who will be Embedded with an intravenous artery fistula will be randomly selected using WWW. Randomizer.Org.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht Ave.,Azadi Ave.,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-05-21, 1397/02/31
Ethics committee reference number
IR.tbzmed.rec.1397.169
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
wound infection
Timepoint
one week,15 days and one month after surgery
Method of measurement
Observed by the responsible physician
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Only single dose of cefalexin 500 mg will be given before surgery
Category
Prevention
2
Description
Intervention group: Single dose of cefalexin 500 mg will be given before surgery and will continue up to 10 days with a dose adjustment based on kidney failure (until removing stitches).
Category
Prevention
3
Description
Control group: Antibiotics will not be given
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgery Ward of Imam Reza hospital
Full name of responsible person
Dr Farzad Kakaei
Street address
Golgasht Ave.,Azadi Ave.,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614695
Phone
+98 41 3334 1317
Email
fkakaei@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolqasem Jouyban
Street address
Golgasht Ave.,Azadi Ave.,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5169664339
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Kakaei
Position
Associate Professor of General and Vascular Surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Surgery Group, Imam Reza Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614695
Phone
+98 41 3333 1317
Email
Fkakaei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Amir Alilou
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Surgery group, Imam Reza hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5157814756
Phone
+98 41 3333 4346
Email
Amiraliloumed91@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Kakaei
Position
Associate Professor of General and Vascular Surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Surgery Group, Imam Reza Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614695
Phone
+98 41 3333 1317
Email
Fkakaei@yahoo.com
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