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The Evaluation of effectiveness of betadine (Povidone-iodine) in one step and two step procedure in the treatment of patients with pleural effusion resistant to conventional treatments: a clinical trial

Protocol summary

Study aim
The aim of this study was to evaluate the effectiveness of betadine as a chemical agent for pleurisy, which will be performed in two steps.
Design
This study was performed on 40 patients with refractory pleural effusion. The present intervention involves injecting 20 cc of 10% betadine with 5 cc of lidocaine and 60 cc of normal saline. The injection is done through a catheter. Two hours after the injection, the catheter is closed and the position is changed, and after 2 hours, the catheter valve is opened again, and finally, after 24 hours, the catheter is removed. After the intervention, patients are cared for.
Settings and conduct
The present study is a clinical trial with one arm that will be performed in 1400 in Afzalipour Hospital in Kerman. In this study, which will be done as a pilot
Participants/Inclusion and exclusion criteria
In this study, patients with refractory pleural effusion with adhesions and a history of VATS and thoracoscopy met the inclusion criteria.
Intervention groups
In this study, patients with refractory pleural effusion with adhesions and a history of VATS and thoracoscopy met the inclusion criteria. The present intervention included injection of 20 cc of 10% betadine with 5 cc of lidocaine and 60 cc of normal It is saline. The injection is done through a catheter. Two hours after the injection, the catheter is closed and the position is changed, and after 2 hours, the catheter valve is opened again, and finally, after 24 hours, the catheter is removed. After the intervention, patients are cared for.
Main outcome variables
Age, sex, type of pleural effusion, duration of follow-up, effectiveness, side effects, reduction of pleural effusion, reduction of clinical symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220117053750N1
Registration date: 2022-02-28, 1400/12/09
Registration timing: registered_while_recruiting

Last update: 2022-02-28, 1400/12/09
Update count: 0
Registration date
2022-02-28, 1400/12/09
Registrant information
Name
Frank Salajegheh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 8325
Email address
f.salajegheh@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Evaluation of effectiveness of betadine (Povidone-iodine) in one step and two step procedure in the treatment of patients with pleural effusion resistant to conventional treatments: a clinical trial
Public title
The Evaluation of effectiveness of betadine (Povidone-iodine) in one step and two step procedure in the treatment of patients with pleural effusion resistant to conventional treatments: a clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
In this study, patients with refractory pleural effusion with adhesions and a history of VATS and thoracoscopy are eligible for the study.
Exclusion criteria:
In contrast, patients who have a mass for whom catheterization is not possible will be excluded from the study process
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Emam Blv., Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913355
Approval date
2022-01-22, 1400/11/02
Ethics committee reference number
IR.KMU.AH.REC.1400.158

Health conditions studied

1

Description of health condition studied
Resistant pleural effusion
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pleural effusion, reduction of pleural effusion
Timepoint
monthly
Method of measurement
Ultrasound of the pleural space

Secondary outcomes

1

Description
Reduce dyspnea and cough
Timepoint
One week after pleural effusion injection
Method of measurement
In this study, a data collection form (Checklist) will be used to collect data. This form consists of 4 main parts. In the first part, the demographic characteristics of patients, including age and sex, as well as the type of pleural effusion disease, which is benign and malignant, are recorded. In the second part, the form of thyroid and kidney enzymes are recorded before and after the intervention. In the third part of the form, the length of the follow-up period and the final outcome of the treatment, which includes the success of the treatment and the failure of the treatment, are recorded. Side effects and patient complaints including chest pain, fever, shortness of breath, hypotension, vision loss, and air leakage are recorded at the end of the form.

Intervention groups

1

Description
Intervention group:In this study, 20 patients received betadine in one step. 20 cc of 10% betadine is injected with 60 cc of normal saline and 5 cc of lidocaine and the catheter is removed and two weeks after betadine injection is removed with a needle. In the second group, we inject 10 cc of betadine along with 30 cc of normal saline and 5 cc of lidocaine and hold the catheter. Two weeks later, we inject 10 cc of betadine with 30 cc of normal saline and 5 cc of lidocaine. Two hours after the injection, the catheter is closed and the position is changed, and after 2 hours, the catheter valve is opened again, and finally, after 24 hours, the catheter is removed, and the patients return two weeks later to remove the betadine. After the intervention, patients are cared for.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Faranak Salajegheh
Street address
Emam Blv., Afzalipour Hospital
City
kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8325
Email
f.salajegheh@kmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Faranak Salajegheh
Street address
Emam Blv., Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8325
Email
f.salajegheh@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Faranak Salajegheh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Emam Blv., Afzalipou Hospital
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8325
Email
f.salajegheh@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Faranak Salajegheh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Emam Blv., Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8325
Email
f.salajegheh@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Faranak Salajegheh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Emam Blv., Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8325
Email
f.salajegheh@kmu.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
The clinical results obtained from the study are published in the article while maintaining the confidentiality of patient data.
When the data will become available and for how long
The information obtained from the test results will be published in the article no later than 12 months later.
To whom data/document is available
Academic and scientific researchers
Under which criteria data/document could be used
Academic and scientific researchers with the condition of maintaining the confidentiality of patients' information
From where data/document is obtainable
Email the responsible author
What processes are involved for a request to access data/document
After requesting in the email and confirmation of the researcher, the requested information will be sent via Orchid two weeks later.
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