The aim of this study is to compare the Antibacterial Effects of Matrica and Chlorhexidine 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 two equal (30 persons) groups: 1- Chlorhexidine group (control) 2- Matrica group (intervention). The patients will be matched by drug regimen,duration of ICU and hospital stay, and frequency of mouth washing with normal saline before study. In both group, 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 matrica 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 pneumoccocus. The antibacterial effects of mouthwashes will be determined by significant decrease of the total number of S.aureus and pneumoccocus after using mouthwashes
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904244365N2
Registration date:2010-08-24, 1389/06/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-08-24, 1389/06/02
Registrant information
Name
Afshin Gholipour Baradari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 1245
Email address
gholipourafshin@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
2010-08-22, 1389/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Antibacterial Effects of Matrica and Chlorhexidine Mouthwashes in ICU patients
Public title
Comparison of the Antibacterial Effects of Matrica and Chlorhexidine Mouthwashes in ICU patients
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 days, GCS< 8, More than 106 bacteria in salivary sample before mouthwash usage
Exclusion Criteria: Re-intubation, History of antibiotic therapy before admission, Oral anticoagulation therapy, CHF and Hypertension (BP > 140/90), 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, Negative cultures of S.aureus and pneumoccocus before use of mouthwash, Occurrence of any reaction to Mouthwashes
Age
From 15 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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
sari
Postal code
46175866
Approval date
2010-08-04, 1389/05/13
Ethics committee reference number
89-55
Health conditions studied
1
Description of health condition studied
ventilator associated pneumonia
ICD-10 code
j13-j15.2
ICD-10 code description
Pneumonia due to Streptococcus pneumoniae-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
Secondary outcomes
1
Description
any reaction to Mouthwashes
Timepoint
after using of mouthwashes
Method of measurement
inspection
Intervention groups
1
Description
All surfaces of mouth, gingiva, tongue, throat and teeth will be swapped carefully by 10 cc of Chlorhexidine 0.2 % mouthwash for 6 minutes
Category
Prevention
2
Description
All surfaces of mouth, gingiva, tongue, throat and teeth will be swapped carefully by 10 cc of matrica mouthwash for 6 minutes
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
ICUs of Imam Khomeini General Hospital
Full name of responsible person
Afshin Gholipour Baradari, MD, CCMF, Assistant professor
Street address
Imam Khomeini general Hospital, Amir St.
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
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Hadi Darvishi Khezri
Position
MSc of Critical care nursing-Nurse of ICU
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
48175-866
Phone
+98 15132612458
Fax
+98 15 1326 2679
Email
hadidarvishi87@yahoo.com
Web page address
www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Afshin Gholipour Baradari MD
Position
CCMF, Assistant Professor, Chief of ICU
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Moallem Square