Comparison of the effect of two hand antisepsis methods before surgery
Design
This clinical trial with a control and intervention group will be conducted in parallel, single blinded and randomization in phase 3 on 50 students. For randomization, the table of random numbers made by the computer will be used.
Settings and conduct
This study will be carried out in the operating room and taking microbial cultures from the hands of the participants of the intervention and control groups in three stages before hand antisepsis, immediately after hand antisepsis and after the end of the surgery and removal of gloves. The microbiologist who will report the microbial load and the statistical consultant who will perform the data analysis will be unaware of the group assignment.
Participants/Inclusion and exclusion criteria
Students of the 5th and 7th semesters of the surgical technology
surgical time duration about 2 hours
principled Removing gown and gloves
non-occurrence of tearing and piercing of gloves
Intervention groups
In this study, the control group will perform surgical hand antisepsis using povidone iodine and brush, and the intervention group will perform surgical hand antisepsis using povidone iodine and sponge.
Main outcome variables
microbial load; antimicrobial residual effect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240212060968N1
Registration date:2024-06-05, 1403/03/16
Registration timing:registered_while_recruiting
Last update:2024-06-05, 1403/03/16
Update count:0
Registration date
2024-06-05, 1403/03/16
Registrant information
Name
Faeze Fakhri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4600
Email address
faeze.fakhri76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-13, 1403/01/25
Expected recruitment end date
2024-07-17, 1403/04/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two methods of surgical hand antisepsis on microbial load and antimicrobial residual effect
Public title
Comparison of the effect of two methods of surgical hand antisepsis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Students of the 5th and 7th semesters of the surgical technology
Not using antimicrobial soap before hand antisepsis on the day of sampling
Not using skin creams and lotions before hand antisepsis on the day of sampling
Not using antibiotics from 7 days before sampling
surgery time duration about 2 hours (between 1:45 and 2:15 hours).
Exclusion criteria:
Puncture or tearing of gloves during surgery
Removing gloves in an unprincipled way at the end of surgery
Removing gloves before removing the surgical gown
The presence of wounds and skin injuries in the hand
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
3
A microbial culture sample will be taken from each participant's hand in three stages before hand antisepsis, immediately after hand antisepsis and after the end of surgery and glove removal.
Randomization (investigator's opinion)
Randomized
Randomization description
we have access to fifty surgical technology undergraduate students in sixth and eighth semester. all of them will be included in our study with census method. We will divide this number of students into two intervention and control groups of Twenty-five using a simple randomization method (Computer generated random numbers table).
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, single blinding will be used so that the microbiologist and the data analysts will not be aware of the allocation of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Faculty of allied medicine, Iran University of Medical Sciences, Next to the Milad tower, Hemmat highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-02-05, 1402/11/16
Ethics committee reference number
IR.IUMS.REC.1402.1009
Health conditions studied
1
Description of health condition studied
surgical site infection
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
microbial loads
Timepoint
Taking microbial cultures before hand antisepsis, immediately after surgical hand hand antisepsis and after surgery and removing gloves (about two hours after surgical hand antisepsis)
Method of measurement
Preparing microbial culture and counting microbial colonies 24 hours after incubation
2
Description
antimicrobial residual effect
Timepoint
Preparation microbial culture after the end of surgery and removal of gloves (after about 2 hours of surgical hand antisepsis)
Method of measurement
Preparing microbial culture and counting microbial colonies 24 hours after incubation
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In order to perform surgical hand antisepsis, the samples will first wash their hands medically with soap and water for 40 seconds under the supervision of the researcher and then rinse. Then they will dry their hands with paper towels. Then the researcher will take a sample from the dominant fingers and palm of each person using a swab moistened with sterile physiological serum. Then the samples will wash their hands with a sterile disposable brush and povidone iodine 7.5% for 5 minutes (90 seconds right hand, 60 seconds right forearm, 90 seconds left hand and 60 seconds left forearm) and dry with a sterile towel. Then the researcher will again take samples from the dominant fingers and palms of each person in the group using a swab moistened with sterile physiological serum. Then, the samples will wear sterile gowns and gloves (in a closed method) and will participate in a general surgery for about 2 hours. After the surgery is completed and the gloves are safely removed (the samples will first remove the gloves and then the gloves), the researcher will take samples from the dominant fingers and palms of each of them again with a swab moistened with sterile physiological serum.
Category
Prevention
2
Description
Intervention group: In order to perform surgical hand antisepsis, the samples will first wash their hands medically with soap and water for 40 seconds under the supervision of the researcher and then rinse. Then they will dry their hands with paper towels. Then the researcher will take a sample from the dominant fingers and palm of each person using a swab moistened with sterile physiological serum. Then the samples will wash their hands with a sterile disposable sponge and povidone iodine 7.5% for 5 minutes (90 seconds right hand, 60 seconds right forearm, 90 seconds left hand and 60 seconds left forearm) and dry with a sterile towel. Then the researcher will again take samples from the dominant fingers and palms of each person in the group using a swab moistened with sterile physiological serum. Then, the samples will wear sterile gowns and gloves (in a closed method) and will participate in a general surgery for about 2 hours. After the surgery is completed and the gloves are safely removed (the samples will first remove the gloves and then the gloves), the researcher will take samples from the dominant fingers and palms of each of them again with a swab moistened with sterile physiological serum.
5th floor of the central headquarters, Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
Falak.r@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Fardin Amiri
Position
Assistant professor, faculty member of the operating room group
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Department of operating room, faculty of allied sciences, Iran university of medical sciences, Shahid Hemat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4600
Email
amiri.fa@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fardin Amiri
Position
Assistant professor, faculty member of the operating room group
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Department of operating room, faculty of allied sciences, Iran university of medical sciences, Shahid Hemat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4600
Email
amiri.fa@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Faeze Fakhri
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
surgical technology
Street address
Department of operating room, faculty of allied sciences, Iran university of medical sciences, Shahid Hemat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4600
Email
Faeze.Fakhri76@gmail.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
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Only a part of the data, such as the information related to the main result or the like, can be shared.
When the data will become available and for how long
The access period starts after the results are printed
To whom data/document is available
Students, employees and researchers in academic and clinical institutions of medical sciences
Under which criteria data/document could be used
Researcher working in academic institutions of medical sciences
From where data/document is obtainable
To access the data, refer to the person responsible for updating the project information.
Name and surname: Faeze Fakhri
Email address: Faeze.Fakhri76@gmail.com
Contact number: 00989108082201
What processes are involved for a request to access data/document
In order to access the data, corresponded with the person in charge of updating the project information via email, and if the thesis project supervisor approves, the project data will be available to the applicants.