To find out which concentrations of povidone-iodine are effective in sterilizing ophthalmic operations, based on the lowest possible concentration
Design
Parallel clinical trial design was employed to achieve aforementioned objectives. 60 patients will be assigned to join the study group
Settings and conduct
60 patients undergoing to ophthalmic surgery who were admitted to Ibn Al-Haitham eye teaching hospital at Baghdad city . On-randomized probability sample
Participants/Inclusion and exclusion criteria
Inclusion criteria: all patients undergoing to ophthalmic surgery, male and female and all ages , exclusions criteria:patient refused
Intervention groups
The start point of intervention phase will start by applying povidon iodine on the eye fore 3 minutes before surgery and take swab from eyelid , eyelashes and conjunctiva and send to culturing.
Main outcome variables
The sterilization will occur with this concentration of povidon-iodine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211022052840N2
Registration date:2023-07-13, 1402/04/22
Registration timing:prospective
Last update:2023-07-13, 1402/04/22
Update count:0
Registration date
2023-07-13, 1402/04/22
Registrant information
Name
Omar AL-Ghrairi
Name of organization / entity
University of Baghdad, College of Nursing
Country
Iraq
Phone
+964 1 521 1495
Email address
omar.thamer1202a@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Povidon-iodine Concentration Intervention on ophthalmic Surgeries Sterilization: Randomized Clinical Trial
Public title
Povidon-iodine Preparation Intervention on ophthalmic Surgeries Sterilization
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
All ocular surgeries
Exclusion criteria:
Patient refused
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A simple random sample that includes applying povidone-iodine in different concentrations before ophthalmic surgeries, where a concentration of 10% is applied, and then we take a swab from the eyelid and eyelashes conjunctiva
In the second group, the experiment is conducted by applying sterilization at a concentration of 5%, and swabs are taken from the eyelids, eyelashes, and eye conjunctiva.
In the third group, a concentration of 2.5% is applied and swabs are taken from the eyelids, eyelashes, and eye conjunctiva
These swabs are sent to the laboratory for the purpose of cultivation and examination of whether bacterial growth has occurred
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind: the participants, investigators or the assessors of the outcomes unaware of the intervention
Placebo
Not used
Assignment
Parallel
Other design features
No one
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethical Approval Committee٬ at the college of nursing
Street address
Bab-AL-Muaadham Street
City
Baghdad
Postal code
10001
Approval date
2066-03-11, 1444/12/21
Ethics committee reference number
3756
Health conditions studied
1
Description of health condition studied
Sterilization of ocular surgeries by applying provide iodine in different concentrations
ICD-10 code
Z30.2
ICD-10 code description
Encounter for sterilization
Primary outcomes
1
Description
Sterilization with less concentrations of povidon iodine to minimize toxicity and no contamination occurs
Timepoint
At same time of surgery
Method of measurement
Swab and culture at laboratory to see if any bacterial growth
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: applying three concentrations of povidon iodine to sterilize eye befor surgery first group with 2.5% the second one 5% and the third group 10% for 3min and take Swab and culture to see bacterial growth and the inner of eye sterilization with tow concentrations 2.5 and 5% for 1min trial will include 60 patients (random sample sampling
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn-AL-Hathim eye Teaching Hospital
Full name of responsible person
Waleed H. Jasm senior doctor ophthalmologist
Street address
Al anduls
City
Baghdad
Postal code
10001
Phone
+964 782 695 6615
Email
omar.thamer1202a@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq./ar/contact-us
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
College of Nursing, Baghdad university
Full name of responsible person
Professor wasaam Jabar ,PhD, Dean
Street address
Bab AL-Muaadam Campus
City
Baghdad
Postal code
10001
Phone
+964 782 695 6615
Email
omar.thamer1202a@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The author of the trial is the funding source
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
College of nursing Baghdad university
Full name of responsible person
Omar Tamer Ghrairi
Position
Nursing specialist
Latest degree
Master
Other areas of specialty/work
Ophthalmology
Street address
Yarmuk
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 782 695 6615
Email
omar.thamer1202a@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
Person responsible for scientific inquiries
Contact
Name of organization / entity
College of Nursing, Baghdad university
Full name of responsible person
Omar Ghrairi
Position
Surgical assistant
Latest degree
Master
Other areas of specialty/work
Ophthalmology
Street address
Yurmouk
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+9648826956615
Email
omar.thamer1202a@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
Person responsible for updating data
Contact
Name of organization / entity
Nursing College, Baghdad university
Full name of responsible person
Omar Ghrairi
Position
Surgical assistant
Latest degree
Master
Other areas of specialty/work
Ophthalmology
Street address
Yurmok
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 782 695 6615
Email
omar.thamer1202a@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
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
The researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals
When the data will become available and for how long
God willing, once finishing the process of data collection, analysis and successfully publishing the manuscript, all the related files will become available for 6 months after publications
To whom data/document is available
All the related files will be shared with any scientific interested parties.
Under which criteria data/document could be used
It may be used after seeking the author's permission and acknowledging his contribution.
From where data/document is obtainable
The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: Omar.thamer1202a@conursing.uobaghdad.edu.iq
What processes are involved for a request to access data/document
N/V
Comments
Appreciation and thanks to IRCT members for their efforts in supporting researchers