To evaluate the incidence of surgical site infection in intervention and control groups.
Design
The aim of this study was to evaluate the effectiveness of antiseptic shower in prevention of surgical site infection.It is a clinical trial with control groups with parallel groups and double blinded. Simple randomization is done by using a random number table. The sample size is 300 people.
Settings and conduct
This study will evaluate the effect of antiseptic shower on prevention of postoperative infection in patients who will referre to Kowsar Hospital in Sanandaj who are diagnosed with inguinal hernia for elective surgery. Patients are divided into three groups. It is two-way blinded, participants, researcher and followers of the outcome, as well as statistical analyzer are unaware of grouping.
Participants/Inclusion and exclusion criteria
All patients who are undergoing elective surgery in the range of 5 to 75 years old with an inguinal hernia diagnosis will be included in the study.
People with immunocompromised, infections or inflammation in the site operation, history of allergy to antiseptic agents and emergency surgery or strangulated hernia will be excluded from the study.
Intervention groups
The first group is the patient who will receive antiseptic shower with a 4% chlorhexidine solution before the operation.
The second group is the patients who will receive a regular detergent before surgery.
The third group is patients who do not receive any type of washing before the surgery.
Main outcome variables
Surgical site infection within a period of 30 days after surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190224042819N1
Registration date:2019-07-24, 1398/05/02
Registration timing:registered_while_recruiting
Last update:2019-07-24, 1398/05/02
Update count:0
Registration date
2019-07-24, 1398/05/02
Registrant information
Name
Ebrahim Khajeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3377 9901
Email address
ebrahim.khajeh@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of preoperative antiseptic showering to prevent surgical site infection, in patients who underwent elective inguinal hernia surgery.
Public title
Effect of antiseptic showering before surgery on preventing surgical site infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Elective inguinal hernia surgery
Age range from 5 to 75 years old
Exclusion criteria:
Immunocompromised patients
Emergency surgery
Strangulated inguinal hernia
Wound or inflammation at surgery site
Allergy to antiseptic agents
Age
From 5 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
In this study we will use table of random numbers for simple randomization method. Unit of randomization is individual. Each patient who came to hospital for elective inguinal hernia surgery, will receive a code at the time of admission. Based on their code they will allocate to one of three different groups of study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be allocat in one of the three study groups based on the admission code. In the ward, the nurse provides the intervention (antiseptic shower or placebo) based on the patient code. At the time of the operation, the surgeon has no information about the grouping of patients. After the discharge of the patients, the investigator will follow-up the outcome (surgical site infection) which also is unaware of the grouping of the participants. Finally, the data analyst will evaluate the outcomes in three groups without knowing their segmentation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan university of medical sciences
Street address
Sanandaj, Pasdaran Ave, Kurdistan unversity of medical sciences
City
sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2019-05-01, 1398/02/11
Ethics committee reference number
IR.MUK.REC.1398.023
Health conditions studied
1
Description of health condition studied
Surgical site infection
ICD-10 code
T81.4
ICD-10 code description
Infection following a procedure
Primary outcomes
1
Description
Surgical site infections (SSIs) are defined as infections occurring up to 30 days after surgery and affecting either the incision or deep tissue at the operation site.
Timepoint
period of 30 days after surgery
Method of measurement
inspection and examination of surgery site
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who receive antiseptic shower with a 4% chlorhexidine solution before surgery.
Category
Prevention
2
Description
Control group: Patients who bath with regular detergents before surgery.
Category
Placebo
3
Description
Control group: Patients who do not receive any shower before surgery.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar hospital
Full name of responsible person
Ebrahim Khajeh
Street address
Pasdaran Ave, Sanandaj, Kurdistan university of medical sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Fax
+98 87 3366 4643
Email
Ebrahim.khajeh@muk.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Farzin Rezaei
Street address
Pasdaran Ave
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
frrezaie@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Ebrahim Khajeh
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Pasdaran Ave, Kowsar hospital
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
Ebrahim.khajeh@muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ebrahim Khajeh
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Pasdaran Ave, Kowsar hospital
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
Ebrahim.khajeh@muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ebrahim Khajeh
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Pasdaran Ave, Kowsar hospital
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
Ebrahim.khajeh@muk.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Except for personal information, the total collected data relates to the participants in the study, as well as the outcome of the intervention will be shared.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
There is no other criteria needed.
From where data/document is obtainable
Contact the researcher: Dr. Ebrahim Khajeh
Mobile: 98 917 361 7490
Email: Ebrahim.khajeh@muk.ac.ir
Ebrahim.khajeh@gmail.com
What processes are involved for a request to access data/document
Applicants will initially submit their application to the researcher and, if approved by the Kurdistan University of Medical Sciences, the information will be provided to them within a period of about one month.