Evaluation of prophylactic antibiotic in prevention of surgical site infection in inguinal hernioplasty with mesh in patients referring Isfahan's Dr. Shariati Hospital
Purpose: This study was designed to evaluate the effect of prophylactic antibiotic in prevention of surgical site infection after hernioplasty with mesh. We will include all male patients who are candidates for elective hernioplasty with mesh and we will exclude patients with indications for emergency surgery such as recurrent or strangulated hernia; positive history of immunosuppressive disease; allergy to the given antibiotic; history of antibiotic usage 3 days before surgery. Material and methods: this study is a double-blind randomized clinical trial. Our estimated sample size of 100 participants. Patients who has the inclusion criteria undergo elective hernioplasty with polypropylene mesh. 30 to 45 minutes before surgery, patients were randomly take 1 gr intravenous cefazolin or the same volume of sterile saline. Patients will be evaluated 1 week, 6-8 week after surgery (according to the Center for Disease Control).The third follow up will be conducted by telephone 12 weeks after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012090210719N1
Registration date:2012-11-28, 1391/09/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-28, 1391/09/08
Registrant information
Name
shahriar barkhordary
Name of organization / entity
islamic azad university, najafabad branch
Country
Iran (Islamic Republic of)
Phone
+98 31 1444 0340
Email address
sh.barkhordary@smd.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad university, Najafabad Branch
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of prophylactic antibiotic in prevention of surgical site infection in inguinal hernioplasty with mesh in patients referring Isfahan's Dr. Shariati Hospital
Public title
The effect of antibiotic prophylaxis in the prevention of surgical site infection after hernia surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all male patients with Primary Inguinal Hernia who are candidates for elective hernioplasty with mesh. Exclusion criteria: patients younger than 18 years old; patients with a recurrent, strangulated, giant scrotal or femoral hernia; patients who are indicated for emergency hernia surgery; patients with a history of diabetes mellitus; patients with underlying heart, liver, renal disease, AIDS or malignancy; patients with American Society of Anesthesiologists
(ASA) scores more than II; patients treated with glucocorticoid; patients with allergy to the given antibiotic; patients taking some antibiotic 3 days prior to surgery; Use of drain; refusing to participate in the study.
Age
From 18 years old to 149 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezarjarib Ave
City
Isfahan
Postal code
Approval date
2012-09-09, 1391/06/19
Ethics committee reference number
491003
Health conditions studied
1
Description of health condition studied
inguinal hernia
ICD-10 code
K40.9
ICD-10 code description
Unilateral or unspecified inguinal hernia, without obstruction or gangrene
Primary outcomes
1
Description
surgical site infection
Timepoint
1, 6-8 and 12 weeks after operation
Method of measurement
Clinical exam, culture and questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
10 cc intravenous sterile saline 30-45 min before surgery in control group
Category
Placebo
2
Description
1 gr intravenous cefazolin 30-45 minutes before surgery in case groupe
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan's Dr. Shariati Hospital
Full name of responsible person
Dr. Behnam Yazdani
Street address
Dr. Shariati Hospital, Shariati Ave
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Najafabad Branch
Full name of responsible person
Dr. Reza Ebrahimi
Street address
Daneshgah Blvd
City
Najafabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Najafabad Branch
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
Islamic Azad University, Najafabad Branch
Full name of responsible person
Shahriar Barkhordary
Position
Intern
Other areas of specialty/work
Street address
Dr. Shariati Hospital, Shariati Ave
City
Isfahan
Postal code
Phone
+98 31 1626 5032
Fax
Email
shbarkhordary@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Najafabad Branch
Full name of responsible person
Dr. Behnam Yazdani
Position
Assistant Professor
Other areas of specialty/work
Street address
Dr. Shariati Hospital, Shariati Ave
City
Isfahan
Postal code
Phone
+98 31 1626 5032
Fax
Email
yazdanibehnam@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Najafabad Branch
Full name of responsible person
Shahriar Barkhordary
Position
Intern
Other areas of specialty/work
Street address
Dr. Shariati Hospital, Shariati Ave
City
Isfahan
Postal code
Phone
+98 31 1626 5032
Fax
Email
shbarkhordary@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)