Evaluation the effect of low level laser therapy with 940 nm wavelength Diode laser on the reduction of post operative scar: a double blind prospective clinical trial study
Evaluation the effects of 940 nm low level diode laser therapy on post operative scar, a clinical trial study
Design
Clinical trial with control group
Settings and conduct
14 Patients who are candidate for elective bilateral facial surgery will be enrolled in the study. They receive bilateral incision, one side irradiated by laser , as case group, and the other one considered as control. Nobody is aware about case and control sides except person who irradiate laser.
4 days after surgery, on suture removal visit (8 days after surgery) and then after two times a week until a month the location of the incision will be irradiated.
Scars will be evaluated on 1st and 6th months after surgery.
laser setting is done to have 4 j/cm2 energy density, 160mw/cm2 power density, 1.5 watt power which is irradiated on a 6.9cm2 area equivalent to 40 J for 26 seconds.
For scar evaluation we use Vancouver analogue scale scoring between 0-13. the higher score is contributed to severe scar.
Participants/Inclusion and exclusion criteria
In the present study 14 patients who are candidates for bilateral elective facial surgery will be recruited after signing informed consent.
Intervention groups
Patients who are candidate for elective bi lateral surgery will be enrolled in the study. They receive bilateral incision the one side irradiated by laser and the other considered as control.
Main outcome variables
Scar severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170919036285N2
Registration date:2019-03-18, 1397/12/27
Registration timing:retrospective
Last update:2019-03-18, 1397/12/27
Update count:0
Registration date
2019-03-18, 1397/12/27
Registrant information
Name
mina jazaeri
Name of organization / entity
Oral Medicine Department
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1059
Email address
m.jazaeri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of low level laser therapy with 940 nm wavelength Diode laser on the reduction of post operative scar: a double blind prospective clinical trial study
Public title
Effect of low level laser therapy on post operative scar
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who sign informed consents form
Those who are candidate for bilateral elective facial surgery
Exclusion criteria:
patients with congenital and acquired dermal diseases
Diabetes
Phenytoin consumption
Chemotherapy
Radiotherapy
Any other diseases which may affect wounds healing
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
14
Randomization (investigator's opinion)
Randomized
Randomization description
Simple, before laser irradiation we will use a coin to decide the side of irradiation. If the numeric side appears, the right side will be irradiated and vise versa.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study the field of surgery in one side irradiated by laser but the other one receive placebo. The person who is responsible for irradiation is the only one who is aware about the side of placebo and laser irradiation.
So patients, surgeon, nurses and assistants of surgery department, surgeon who assess the scar and statistical analyzer are not aware about placebo side.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Blvd, Hamadan University of Medical Sciences, Vice-Chancellor for Research and Technology, Ethics committe
City
Hamadan
Province
Hamadan
Postal code
654178-38741
Approval date
2017-05-27, 1396/03/06
Ethics committee reference number
IR.UMSHA.REC.1396.171
Health conditions studied
1
Description of health condition studied
scar
ICD-10 code
L90.5
ICD-10 code description
Scar conditions and fibrosis of skin
Primary outcomes
1
Description
Scar severity according to VAS
Timepoint
Scar evaluation 1 and 6 months after surgery
Method of measurement
VAS scor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in this group 940 nano meter diode laser, made by BIOASE company of the USA, is used. Irradiation is done on 4th and 8th day after surgery and then after 2 times a week for a month.
Category
Treatment - Other
2
Description
Control group: Laser machine in ready for use status, precisely similar to intervention group will be placed on incision place but no irradiation will be done.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan Besat Hopital
Full name of responsible person
Masih Moosavi Seresht
Street address
Shahid Beheshti Blvd
City
Hamadan
Province
Hamadan
Postal code
6517865123
Phone
+98 81 3264 0030
Email
besat@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Vice-chancellor for Research and Technology
Street address
Shahid Fahmide Blvd
City
Hamadan
Province
Hamadan
Postal code
6516765087
Phone
+98 81 3838 0130
Email
research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr. mina jazaeri
Position
Assistant professor of oral Medicine
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Oral Medicine, School of Dentistry, Shahid Fahmide Blvd., Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
6515565687
Phone
+98 81 3838 1059
Fax
Email
m.jazaeri@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. mina jazaeri
Position
Assistant professor of oral Medicine
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Oral Medicine, School of Dentistry, Shahid Fahmide Blvd., Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
6515565687
Phone
+98 81 3838 1059
Fax
Email
m.jazaeri@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. mina jazaeri
Position
Assistant professor of oral Medicine
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Oral Medicine, School of Dentistry, Shahid Fahmide Blvd., Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
6515565687
Phone
+98 81 3838 1059
Fax
Email
m.jazaeri@umsha.ac.ir
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data could be shared
When the data will become available and for how long
it is reachable after article publication
To whom data/document is available
It is reachable for researchers.
Under which criteria data/document could be used
According to the cases of other researchers will be decided
From where data/document is obtainable
via the email address
m.jazaeri@umsha.ac.ir
What processes are involved for a request to access data/document
6 months after publication by sending email and defining the the cooperation protocol, after 2 weeks data is reachable