The aim of this study is to evaluate the effect of low-power laser in reducing bruising around the eyes after rhinoplasty.
Design
patients are randomly assigned to two groups of control and intervention by using of block randmization
Settings and conduct
All patients referred to Facial Plastic Surgery Clinic was undergoing rhinoplasty
Participants/Inclusion and exclusion criteria
Patients undergoing rhinoplasty are included in study , excluded cases were who need to re operation, patients with systemic disease, or congenital malformation or skin disease that this situations known as contraindications for laser using.
Intervention groups
low power laser used for reducing of edema and bruising after rhinoplasty in intervention group and no intervention used rhinoplasty in control group
Main outcome variables
periorbital ecchymosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080820001056N3
Registration date:2019-01-04, 1397/10/14
Registration timing:retrospective
Last update:2019-01-04, 1397/10/14
Update count:0
Registration date
2019-01-04, 1397/10/14
Registrant information
Name
babak saedi
Name of organization / entity
tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 2270 0765
Email address
saedi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical science
Expected recruitment start date
2017-08-15, 1396/05/24
Expected recruitment end date
2018-08-20, 1397/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of low power laser on reducing preorbital ecchymosis after rhinoplasty in patients admitted in facial plastic surgery clinic
Public title
Effect of low power laser on reducing preorbital ecchymosis after rhinoplasty in patients admitted in facial plastic surgery clinic
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to Facial Plastic Surgery Clinic undergoing rhinoplasty
Exclusion criteria:
history of previous surgery
systemic disease,
congenital malformation
skin disease, which contraindicates the use of laser radiation.
Age
No age limit
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
The method of randomization is 4block numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthical committee of Tehran university of medical science
Street address
Tehran university of medical science, Qods st., Keshavarz blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-08-15, 1396/05/24
Ethics committee reference number
IR.TUMS.VCR.REC.1396.3211
Health conditions studied
1
Description of health condition studied
periorbital ecchymosis
ICD-10 code
S00.1
ICD-10 code description
Contusion of eyelid and periocular area
Primary outcomes
1
Description
rate of periorbital ecchymosis based on the doctor's evaluation
Timepoint
before intervention, one week after intervention
Method of measurement
based on the doctor's evaluation by grading system (0-4)
2
Description
periorbital ecchymosis based on the patient’s evaluation
Timepoint
before intervention, one week after intervention
Method of measurement
based on the patient’s evaluation by VAS (1-10)
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: treatment with low power laser the day after surgery for 15 minutes over nose and face. was made by Meditex company, Canada
Category
Treatment - Other
2
Description
Control group: no intervention
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Babak Saedi
Street address
Keshavarz Blvd Ghods avenu Tehran University
City
Tehran
Province
Tehran
Postal code
141979733141
Phone
+98 21 6658 1628
Email
saedi@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Babak Saedi
Street address
Tehran university of medical science, Qods st., Keshavarz blvd., Tehran
City
Tehran
Province
Tehran
Postal code
141979733141
Phone
+98 21 6658 1628
Email
saedi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran university of medical science
Full name of responsible person
Somaye Karimi
Position
Doctor of Medicine (MD)
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Tehran university of medical science, Qods st., Keshavarz blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6608 6487
Fax
Email
karimisomi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of medical science
Full name of responsible person
Somaye Karimi
Position
Doctor of Medicine (MD)
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Tehran university of medical science, Qods st., Keshavarz blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6608 6487
Fax
Email
karimisomi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Somayeh Karimi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Tehran university of medical science, Qods st., Keshavarz blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1344944676
Phone
+98 21 6608 6487
Fax
Email
karimisomi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
We will published it in article
When the data will become available and for how long
We will published it in article 2018
To whom data/document is available
nobody can have anything more than article
Under which criteria data/document could be used
We will published it in article, but nobody have access to other data
From where data/document is obtainable
We will published it in article
What processes are involved for a request to access data/document