Determining and comparing the effect of using an automatic masking device by removing the mask from the basket on the contamination rate of the masks.
Design
The present study is a clinical trial with a control group, with parallel groups, one-way blind. 120 people will be selected with easy access and will be divided into two equal groups by stratified random block allocation method.
Settings and conduct
The intervention site is the operating room of Ayatollah Kashani Hospital in Isfahan. The research is one-way blind and the statistical analyst does not know the study groups.
Participants/Inclusion and exclusion criteria
Operating room personnel with associate degree, bachelor's and master's degree in operating room, anesthesia, nursing, residents and orthopedic surgery and neurosurgery, insensitivity of the sample to fluorescent powder and participation in surgery for at least one hour.
Intervention groups
Personnel are divided into two groups, A and B. After washing the hands in the standard way, the personnel first take 3 grams of fluorescent powder from a third person who also wears sterile gloves, and with both hands (palm and back of the hand and Between the fingers) they clap from the fingertips to the wrists, and then staff A removes the mask from the basket, and staff B receives the mask.
Main outcome variables
Area of glitterbug powder on surgical masks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150715023216N11
Registration date:2022-01-16, 1400/10/26
Registration timing:retrospective
Last update:2022-01-16, 1400/10/26
Update count:0
Registration date
2022-01-16, 1400/10/26
Registrant information
Name
Said Amini Rarani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3522 6158
Email address
ghadami@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-19, 1400/09/28
Expected recruitment end date
2022-01-09, 1400/10/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using an automatic masking device on the contamination rate of masks.
Public title
Comparison of contamination between two methods of distributing surgical masks among personnel.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Operating room staff with associate, bachelor's and master's degrees in operating room, anesthesia and nursing.
Residents and surgeons in surgery, orthopedics and neurology.
Insensitivity of the sample to fluorescent powder.
Participate in surgery for at least one hour.
Exclusion criteria:
People are not satisfied to participate in the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
First, using the available sampling method, the operating room and anesthesia and nursing staff of the operating room and the operating room, neurology and orthopedics are selected and their inclusion criteria are reviewed. The selection of personnel according to the inclusion criteria and random allocation in a layered block method are placed in two groups A and B. Group A removes the mask from the basket, group B receives the mask from the device. Sampling continues until the required sample size in each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistical analyst does not know what group each sample belongs to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Hazar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Approval date
2021-12-18, 1400/09/27
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.186
Health conditions studied
1
Description of health condition studied
Self-contamination of personnel
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Areas containing glitterbug powder on surgical Mask that indicate contamination will be measured.
Timepoint
before the intervention and one hour after intervention
Method of measurement
by using image j app
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Group A personnel are considered as control group. After washing the hands in the standard way, the personnel first take 3 grams of fluorescent powder from a third person who also wears sterile gloves and apply it to both hands (palm and back of the hand and between the fingers) from the fingertips to the wrists. And then personnel A remove the mask from the basket.
Category
Prevention
2
Description
Intervention group: Group B personnel are considered as intervention group. After washing the hands in the standard way, the personnel first take 3 grams of fluorescent powder from a third person who also wears sterile gloves and take it in both hands (foam and zinc). Behind the hand and between the fingers) from the fingertips to the wrists, then B personnel receive the surgical mask from the automatic masking machine
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Kashani hospital
Full name of responsible person
Dr Ahmad Ghadami
Street address
Ayatollah Kashani hospital, Kashani Street, Isfahan city, Isfahan province, Iran
City
Esfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
Kashani@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo
Street address
Isfahan university of medical sciences, Hezar Jarib street, Isfahan city, Isfahan province, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dَr Ahmad Ghadami
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
NO 127, 22 Bahman alley, Raran St, Khorasegan city, Isfahan province, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 5226 1158
Email
ghadami@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Ahmad Gadami
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
NO 127, 22 Bahman alley, Raran St, Khorasegan city, Isfahan province, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 5226 1158
Email
ghadami@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Ghadami
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
NO 127, 22 Bahman alley, Raran St, Khorasegan city, Isfahan province, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 5226 1158
Email
ghadami@mui.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
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
Individual participant data collected for the primary outcome measures
When the data will become available and for how long
After publication for one year
To whom data/document is available
For all people who request for data
Under which criteria data/document could be used
It is allowed to perform any analysis on the data, but use of data for publication is not allowed.
From where data/document is obtainable
Corresponding author of article
What processes are involved for a request to access data/document
After requesting the data by email to corresponding author , the data will be sent after a maximum period of one week