The aim of this study is to compare the Antibacterial Effects of Chlorhexidine, persica and normal saline Mouthwashes in ICU patients. This is a randomized double blind clinical trial which will be done on 60 patients who will be admitted to ICUs of Imam Khomeini General Hospital and meet inclusion criteria. Patients will be randomly assigned into three equal (20 persons) groups: 1. Chlorhexidine group 2. persica group 3. normal saline group. In three groups, all surfaces of mouth, gingiva, tongue, throat and teeth will be swapped carefully by 10 cc of mouthwashes (Chlorhexidine 0.2 % in the first group and persica in second group) for 6 minutes. Immediately before and after using mouthwashes, salivary sample without any stimulation will be taken for culturing S.aureus and pneumococcus. The antibacterial effects of mouthwashes will be determined by the presence or absence of S. aureus and pneumoncoccus in samples after rinsing. To compare the number of bacterial colony ANOVA Test and for Comparison of S. aureus and pneumococcal in a group McNemar Test and between three groups Chi-Square Test were used.
General information
Acronym
persica
IRCT registration information
IRCT registration number:IRCT138903254190N1
Registration date:2010-12-29, 1389/10/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-12-29, 1389/10/08
Registrant information
Name
Hadi Darvishi Khezri
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 15 1227 2472
Email address
h.darvishi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2010-10-23, 1389/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the immediate Antibacterial Effects of persica , Chlorhexidine and normal saline Mouthwash in ICU patients
Public title
Antibacterial effects of chlorhexidine , persica and saline mouthwashes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Age between 15-65 years, Third and fourth day of admission in ICU, Intubation and mechanical ventilation for 3 to 4 days, having NG tube for 3 to 4 Exclusion Criteria: Re-intubation, History of antibiotic therapy before admission, Oral anticoagulation therapy,Respiratory and systemic infection, Autoimmune diseases and malignancies, History of allergy to mouthwash, asthma, allergic rhinitis and dermatitis, History of radiation therapy and immunosuppressive therapy including corticosteroid, Use of any kind of antimicrobial mouthwash within 2 months before admission, Diseases of oral mucosa and severe periodontitis, History of splenectomy and Tonsillectomy , Negative cultures of S.aureus and pneumoccocus before use of mouthwash, Occurrence of any reaction to Mouthwashes
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this double blind randomized clinical trial samples in the three groups will be labeled by letters A, B and C and Laboratory staffs are unaware of the intervention groups. Patients are also blind as they are unconscious at the time of intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of research of Mazandaran University of medical sciences
Street address
Moalem Square, Deputy of research of Mazandaran University of medical sciences
City
Sari
Postal code
48175-866
Approval date
2010-09-29, 1389/07/07
Ethics committee reference number
89-101
Health conditions studied
1
Description of health condition studied
ventilator associated pneumonia
ICD-10 code
J13
ICD-10 code description
Pneumonia due to Streptococcus pneumoniae
2
Description of health condition studied
ventilator associated pneumonia
ICD-10 code
J15.2
ICD-10 code description
Pneumonia due to staphylococcus
Primary outcomes
1
Description
number of colony of S.aureus and pneumoccocus
Timepoint
Immediately before and after using mouthwashes
Method of measurement
CFU(Colony-forming unit)
Secondary outcomes
1
Description
any reaction to Mouthwashes
Timepoint
after using of mouthwashes
Method of measurement
inspection
Intervention groups
1
Description
In first group, will used chlorhexidine gluconate 0.2% mouthwash, manufactured by pharmaceutical company of drug city (Tehran – Iran).all surfaces of mouth, gingiva, tongue, throat and teeth will be swapped carefully by 10 cc of mouthwashes (chlorhexidine gluconate 0.2%) for 6 minutes. Immediately before and after using of mouthwashes, salivary sample without any stimulation was taken for culturing S.aureus and pneumoccocus.
Category
N/A
2
Description
In second group, will used persica 10% mouthwash, manufactured by pharmaceutical company of pursina. all surfaces of mouth, gingiva, tongue, throat and teeth will be swapped carefully by 10 cc of mouthwashes (persica 10%) for 6 minutes. Immediately before and after using of mouthwashes, salivary sample without any stimulation was taken for culturing S.aureus and pneumoccocus.
Category
N/A
3
Description
In third group, will used normal salin mouthwash. all surfaces of mouth, gingiva, tongue, throat and teeth will be swapped carefully by 10 cc of mouthwashes (normal salin) for 6 minutes. Immediately before and after using of mouthwashes, salivary sample without any stimulation was taken for culturing S.aureus and pneumoccocus.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
ICUs of Imam Khomeini General Hospital
Full name of responsible person
Hadi darvishi khezri-MSc of critical Care Nursing
Street address
Imam Khomeini general Hospital
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati MD
Street address
Deputy of research of Mazandaran University of medical sciences
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?