Effect of % 2 mupirocin intranasal ointment before and during nasotracheal intubation on decreasing its complications in oral and maxillofacial surgery
The aim of this study is to evaluate the effect of % 2 mupirocin intranasal ointment before and during nasotracheal intubation on decreasing its complications in oral and maxillofacial surgery. Fifty four patients who are candidate for maxillofacial surgery will be selected randomly and after providing written consent form, will be randomly divided into the two groups with Randlist software. The Study group will apply 2% mupirocin, while control group won't apply. Finally, two groups will be compared and analyzed with extent of complications in different times. The researcher will be blind to the study(single blind).
Inclusion criteria: All patients who are going to have maxillofacial surgery.
Exclusion criteria: contraindications of nasotracheal intubation, Chronic sinusitis, upper airway infections, allergy to mupirocin.
Outcomes of the study: Endotracheal nasal tube bacterial load, nasal congestion, facilitate breathing through the nose and Ease of extubation that are evaluated by observational scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102122951N2
Registration date:2016-12-18, 1395/09/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-18, 1395/09/28
Registrant information
Name
milad Ghanizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5921
Email address
milad.ghanizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2016-03-24, 1395/01/05
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of % 2 mupirocin intranasal ointment before and during nasotracheal intubation on decreasing its complications in oral and maxillofacial surgery
Public title
Management of nasotrancheal intubation complications
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All patients who are going to have maxillofacial surgery and nasotracheal intubation; age from 20 to 60 years
Exclusion criteria: contraindications of nasotracheal intubation; nasal polyps; Chronic sinusitis; upper airway infections; allergy to mupirocin; pregnancy and lactation.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Postal code
Approval date
2016-02-15, 1394/11/26
Ethics committee reference number
IR.TBZMED.REC.1394.20
Health conditions studied
1
Description of health condition studied
Endotracheal nasal tube bacterial load
ICD-10 code
J60-J70
ICD-10 code description
Lung diseases due to external agents
Primary outcomes
1
Description
Endotracheal nasal tube bacterial load
Timepoint
after surgery
Method of measurement
Microbial culture
2
Description
nasal congestion
Timepoint
0, 2, 4, 6, 12 hours After anesthesia
Method of measurement
questionnaire
3
Description
facilitate breathing through the nose
Timepoint
0, 2, 4, 6, 12 hours After anesthesia
Method of measurement
questionnaire
4
Description
Ease of extubation
Timepoint
After anesthesia
Method of measurement
check list
Secondary outcomes
empty
Intervention groups
1
Description
8 hours before and during nasoracheal intubation, nasal ointment of 2 % mupirocin will apply.
Category
Prevention
2
Description
In the control group, this ointment not be used.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tabriz University of Medical Sciences
Full name of responsible person
DR. Korosh Taheri Talesh
Street address
Research deputy of Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
DR. Monire Roshandel
Position
Resident of oral and maxillofacial surgery
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 9680
Fax
Email
milad.ghanizadeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
DR Monire Roshandel
Position
Resident of Oral and maxillofacial surgery
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 9680
Fax
Email
milad.ghanizadeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
DR Monire Roshandel
Position
Resident of Oral and maxillofacial surgery
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 9680
Fax
Email
milad.ghanizadeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)