Comparison of the effect of chlorhexidine, normal saline and nystatin in the prevention of oral candidiasis in patients admitted to the ICU of Tohid Hospital in Sanandaj
Determining the effect of chlorhexidine, nystatin and normal saline mouthwashes in preventing oral candidiasis in patients admitted to ICU
Design
This study is a double-blind randomized clinical trial.
Settings and conduct
This study is a double-blind randomized clinical trial to evaluate and compare the effects of nystatin, normal saline and 0.2% chlorhexidine gluconate mouthwashes in the prevention of oral candidiasis. Patients admitted to the ICU of Tohid Teaching Hospital in Sanandaj to be included in the study, using block randomization patients are divided into three groups (5 blocks of 9).In this way, each patient is placed in one of the three groups as soon as he enters the ICU.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients admitted to ICU of Tohid Hospital in Sanandaj
exclusion criteria:
Clinical observation of oral candidiasis or the presence of more than 50 Candida colonies at the time of admission.
The patient's condition is such that he is likely to stay in the ICU for less than 5 days.
Existence of any oral diseases
Lack of patient cooperation until the end of the hospitalization period
Intervention groups
Nystatin and chlorhexidine and normal saline
Main outcome variables
1.Oral candidiasis
2. Nystatin: is a polynovial mouthwash, a tetramacroloid antibiotic compound.
3. Chlorhexidine: A baseless guanide antiseptic that works against a wide range of bacteria, some fungi, and some viruses.
4. Normal saline: Crystalloid solution containing Na and Cl electrolytes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170417033483N3
Registration date:2020-10-05, 1399/07/14
Registration timing:prospective
Last update:2020-10-05, 1399/07/14
Update count:0
Registration date
2020-10-05, 1399/07/14
Registrant information
Name
Hero Azizzadeh
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87336646456
Email address
h.azizzadeh@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-03-15, 1399/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of chlorhexidine, normal saline and nystatin in the prevention of oral candidiasis in patients admitted to the ICU of Tohid Hospital in Sanandaj
Public title
Comparison of chlorhexidineو normal saline, and nystatin in prevention of oral candidiasis in ICU admitted patients of Tohid hospital of sanandaj
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients admitted to the intensive care unit
Exclusion criteria:
Clinical oral candidiasis
Existence of more than 50 Candida colonies at the time of admission
The patient's condition is such that he is likely to stay in the ICU for less than 5 days.
Existence of any oral diseases
Lack of patient cooperation until the end of the hospitalization period
Age
From 14 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization، Individual، Sealed envelope
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant: ICU patients who are not aware of the type of mouthwash they receive.
Researcher: The sealed envelopes provided by the statistical consultant to the clinical caregiver and he is not aware of their contents.
Outcome Evaluator: A person who does not know the type of mouthwash used by patients and examines the mouth of patients twice a day before giving mouthwash for candidiasis.
Data Analyzer: Receives the data extracted from the questionnaires by the researcher and is not aware of the mouthwash received by each patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran St., Shadi hotel in front of., Kurdistan University of Medical Sciences
City
sanandaj
Province
Kurdistan
Postal code
66177-15175
Approval date
2015-05-10, 1394/02/20
Ethics committee reference number
IR.MUK.REC.1394.67
Health conditions studied
1
Description of health condition studied
Oral candidiasis
ICD-10 code
B37.0
ICD-10 code description
Candidal stomatitis
Primary outcomes
1
Description
Oral infection with Candida albicans yeast in more than 50 colonies
Timepoint
In 4 stages of admission, on the 5th day and on the 10th and 14th day of admission, sample patients are taken for colony count, respectively.
Method of measurement
Patients are forbidden to eat or drink for at least 2 hours before sampling. Sterile swabs are stretched with relatively strong movement on the palate, tongue and cheeks and are immediately transferred to the culture medium.
Secondary outcomes
1
Description
Oral diseases
Timepoint
Daily every 12 hours
Method of measurement
observation
Intervention groups
1
Description
Intervention group: Chlorhexidine mouthwash every 12 hours for 14 days
Category
Prevention
2
Description
Intervention group: Nystatin mouthwash every 12 hours for 14 days
Category
Prevention
3
Description
Control group: Normal saline every 12 hours for 14 days
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Tohid Hospital, Sanandaj
Full name of responsible person
Hero azizzadeh
Street address
Pasdaran St.,
City
sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 1613 1281
Email
Heroazizzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Hero azizzadeh
Street address
Pasdaran St.,
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 1613 1281
Email
Heroazizzadeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Hero azizzadeh
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Pasdaran St.,
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 1613 1281
Email
Heroazizzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Hero azizzadeh
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Pasdaran St.,
City
sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 1613 1281
Email
Heroazizzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Hero azizzadeh
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Pasdaran St.,
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 1613 1281
Email
Heroazizzadeh@yahoo.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
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