Evaluation of surgical site infection in Mesh Hernioplasty with or without glove change
Design
A concealed, blinded, sham-controlled clinical trial with parallel groups. Patients are randomly divided into two groups. The risk of infection in the placement of the mesh by changing gloves and without changing in the inguinal hernia is assessed.
Patients are matched in terms of sex and type of hernia. Indeed six lines are created for random allocation, and the entered individuals in each line are assigned to group A or B by a simple randomization method. The assignor does not have contact with subsequent evaluators. Patients are randomly divided into 2 groups of 100, using codes A and B that patients choose before surgery. Preoperative prophylaxis is done but no antibiotics are given after the surgery. All patients are thoroughly examined in the outpatient clinic on the day of discharge from the hospital (second day after surgery) and 10 and 30 days after surgery.
Settings and conduct
In this double-blind study, the nurse and evaluator are unaware of grouping.
This study will be performed in Imam Reza Hospital of Mashhad. Patients referred to the surgical ward of Imam Reza Hospital will be selected. These patients will be all candidates for inguinal hernia surgery with mesh.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Conscious satisfaction, candidate for inguinal hernia surgery with mesh, no underlying diseases such as diabetes.
Exclusion criteria: dissatisfaction with inclusion in the study, having an underlying disease such as diabetes.
Intervention groups
Intervention group: Changing gloves during the operation.
Control group: No gloves replacement during the operation
Main outcome variables
Wound infection after inguinal hernia surgery with mesh
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090124001581N4
Registration date:2021-05-18, 1400/02/28
Registration timing:registered_while_recruiting
Last update:2021-05-18, 1400/02/28
Update count:0
Registration date
2021-05-18, 1400/02/28
Registrant information
Name
Mohammad Reza Motie
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5255
Email address
motiem@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2022-11-06, 1401/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of surgical site infection in Mesh Hernioplasty in with or without glove change
Public title
Evaluation of surgical site infection in Hernioplasty in with or without glove change
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious satisfaction,
candidate for inguinal hernia surgery with mesh,
no underlying diseases such as diabetes
Exclusion criteria:
dissatisfaction with inclusion in the study,
having an underlying disease such as diabetes
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, health care providers (nurses) and outcome assessors are not aware of the two study groups.
The surgeon knows the groups of patients. Therefore, the evaluator is someone other than the surgeon. Also, after the operation, the nurse does not know about the study groups, and there is no difference in the way of care between the two groups of patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Danehgah street, Ethics committee of Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Approval date
2020-12-09, 1399/09/19
Ethics committee reference number
IR.MUMS.REC.1399.513
Health conditions studied
1
Description of health condition studied
Inguinal hernia
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
Wound infection
Timepoint
On the second, third and thirty days after surgery
Method of measurement
Physical examination and tissue culture
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, glove replacement will be performed during inguinal hernia surgery
Category
Prevention
2
Description
Control group: in the control group, glove replacement is not performed in the inguinal hernia
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital of Mashhad
Full name of responsible person
Mohammdreza Motie
Street address
Malekoshoara Bahar street, Imam Reza Hospital of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3841 2081
Email
Motiem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah St., Alouk University of Medical Sciences, Mashhad, second floor, Vice Chancellor
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3845 1521
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammadreza motie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Reza Hospital of Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
00985138412081 051
Email
motiem@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammadreza Motie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Reza Hospital of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3841 2081
Email
motiem@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammadreza Motie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Reza Hospital of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3841 2081
Email
motiem@mums.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
all collected deidentified IPD are to be shared
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
available for people working in academic institutions
Under which criteria data/document could be used
With the coordination of the corresponding author is determined.
From where data/document is obtainable
Via corresponding author email
What processes are involved for a request to access data/document
Applicants can access the data by emailing the responsible author and a full description of the processes that will be performed on the data.