Comparison between mucoadhesive form from Carbomer and HydroxyPropylCellulose containing commercial chlorhexidine 0.2% and commercial chlorhexidine 0.2% solution for prevention of ventilator associated pneumonia in Intensive Care Unit (ICU) patients
The aim of this study is to investigate the effect of mucoadhesive form from Carbomer and HydroxyPropylCellulose containing commercial Chlorhexidine 0.2% for prevention of ventilator associated pneumonia in Intensive Care Unit (ICU) patients.
Design
64 patients will be included in this randomized controlled clinical trial with parallel, double-blind, randomized groups. Patients will be randomly divided into two groups. In this study, patients are not aware of the treatment group due to the decreased level of consciousness. The researcher who studies the variables, does not know the group of study and mouth wash is prepared by another person. This study is third phase of clinical trial.
Settings and conduct
This study will be conducted on patients underwent mechanical ventilation in ICU units of Ayatollah Mousavi Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Intubated patients; Age between 20 to 50 years; Admission less than 24 hours in intensive care unit
Non-inclusion criteria: Contraindications to any cause to enteral feeding; Pneumonia
Intervention groups
Intervention group:The mucoadhesive mouthwash group will receive 5 ml chlorhexidine 0.2% three times per day which will be produced in mucoadhesive form from Carbomer and HydroxyPropylCellolose containing commercial chlorhexidine 0.2% solution as mouthwash. Control group: The control group will receive 5 ml chlorhexidine 0.2% three times per day.
.
Main outcome variables
concentration of polymer in volume ؛the amount of loading of Cholorhexidine in gel؛ the amount of release of Cholorhexidine in gel; ventilator associated pneumonia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101211005363N14
Registration date:2019-11-15, 1398/08/24
Registration timing:retrospective
Last update:2019-11-15, 1398/08/24
Update count:0
Registration date
2019-11-15, 1398/08/24
Registrant information
Name
Taraneh Naghibi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 2865
Email address
tnaghibi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-08, 1398/01/19
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between mucoadhesive form from Carbomer and HydroxyPropylCellulose containing commercial chlorhexidine 0.2% and commercial chlorhexidine 0.2% solution for prevention of ventilator associated pneumonia in Intensive Care Unit (ICU) patients
Public title
Effect of Chlorhexidine 0.2% in a mucoadhesive polymeric gel from Carbomer and HPC on prevention of ventilator associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 to 50 years
Admission less than 24 hours in intensive care unit
Intubated patient
Satisfaction of patients' families
Exclusion criteria:
contraindications to any cause to enteral feeding
pneumonia
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into two groups with 32 patients in each of them with using Random allocation software. The numbered envelopes will be arranged in the order of 1 to 64, respectively, and within each envelope the type of treatment is specified, which will be executed after the treatment envelope is opened.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients are not aware of the treatment group due to the decreased level of consciousness. The researcher who studies the variables, does not know the group of study and mouth wash is done by another person.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Office of Vice- Chancellor for Research, Zanjan University of Medical Sciences, Azadi square
City
Zanjan
Province
Zanjan
Postal code
4513994945
Approval date
2019-07-30, 1398/05/08
Ethics committee reference number
IR.ZUMS.REC.1398.200
Health conditions studied
1
Description of health condition studied
ventilator associated pneumonia
ICD-10 code
J17.0
ICD-10 code description
Pneumonia in bacterial diseases classified elsewhere
Primary outcomes
1
Description
Concentration of polymer in volume
Timepoint
At the beginning of experiment
Method of measurement
By weighing
2
Description
The amount of loading of cholorhexidine in gel
Timepoint
At the beginning of experiment
Method of measurement
By weighing
3
Description
The amount of release of cholorhexidine in gel
Timepoint
1,2,3 and 4 hours after gel preparation
Method of measurement
Spectrophotometry
4
Description
Ventilator Associated Pneumonia
Timepoint
Third day, Sixth day, Ninth day, The twelfth day
Method of measurement
Clinical Pulmonary Infection Score
Secondary outcomes
1
Description
Mortality rate during hospitalization in Intensive Care Unit
Timepoint
End of the study
Method of measurement
Records
2
Description
Connection to ventilator days
Timepoint
End of the study
Method of measurement
Records
3
Description
length of Intensive Care Unit stay
Timepoint
End of the study
Method of measurement
Records
Intervention groups
1
Description
Intervention group: The first group will receive 5 ml chlorhexidine 0.2% (product of Behsa pharmaceutical company) as mouthwash three times per day in a mucoadhesive form from Carbomer and HydroxyPropylCellulose containing chlorhexidine 0.2% solution prepared at the School of Pharmacy of Zanjan University of Medical Sciences .
Category
Prevention
2
Description
Control group: The control group will receive 5 ml chlorhexidine 0.2% product of Behsa pharmaceutical company three times per day
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mosavi Hospital
Full name of responsible person
Taraneh Naghibi
Street address
Gavazang Road
City
Zanjan
Province
Zanjan
Postal code
4513994945
Phone
+98 24 3313 1559
Email
tnaghibi@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Ali Reza Shoghli
Street address
Vice- Chancellor for Research, Zanjan University of Medical Sciences, Azadi Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513994945
Phone
+98 24 3342 0677
Fax
Email
shoghli@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Farshad Khodami
Position
pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy School, Mahdavi St.
City
Zanjan
Province
Zanjan
Postal code
4513994945
Phone
+98 24 3345 9878
Email
farshadkhodami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Faramarz Dobakhti
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy School, Mahdavi St.
City
Zanjan
Province
Zanjan
Postal code
4513994945
Phone
+98 24 3345 9878
Fax
+98 24 3345 9878
Email
fdobakhti@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Taraneh Naghibi
Position
ICU Fellowship, Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Mosavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513994945
Phone
+98 24 3313 0001
Email
tnaghibi@zums.ac.ir
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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