Investigation of effect of fractional CO2 laser in scar revision of alar base in patients under Rhinoplasty.
Design
Patients are randomly divided into intervention and control groups and the study is design as a randomised, controlled, parallel group trial with double blinded outcome assessment. Randomisation will be centralised based on simple randomization method using random digits table.
Settings and conduct
Thirty patients in age group 18 to 50 years, with a history of open rhinoplasty and subsequent scarring in the alar base region, and 4 months had passed since their surgery at Imam Khomeini Hospital in Ahvaz are randomly divided by simple randomization method into intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria are patients with a history of open rhinoplasty, patients who had scarring in the alar base region following rhinolasty and no history of treatment for the alar base region scarring and four months have passed since the surgery; The exclusion criteria are patients with history of photosensitivity, keloid and hypertrophic scars, systemic disease and immunodeficiency, consumption of anticoagulant drugs and pregnancy and lactation.
Intervention groups
In the Intervention group, one session of laser treatment is performed with Fractional CO2 MORE-XEL -BISON-Korea with radiant characteristics: spot diameter 0.05 mm, pulse duration: 4 ms, laser power 12-14 watts and energy 48-56 mJ per pulse. In the control group, there is no intervention for them to treat the scar.
Main outcome variables
Improvement of scarring in the alar base region will be recorded and compared between two groups based on Vancouver Scar Scale before and 1 month after treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200724048187N1
Registration date:2020-07-27, 1399/05/06
Registration timing:registered_while_recruiting
Last update:2020-07-27, 1399/05/06
Update count:0
Registration date
2020-07-27, 1399/05/06
Registrant information
Name
Farzin Hajizade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8383
Email address
hajizade.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Fractional CO2 Laser in Scar Revision of Alar Base in Patients under Rhinoplasty
Public title
Effect of Fractional Laser in Scar Revision in Patients under Rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a history of open rhinoplasty
Patients who had scarring in the alar base region following rhinolasty
Patients who had no history of treatment for the alar base region scarring
Four months have passed since the surgery
Exclusion criteria:
Patients with history of photosensitivity
Patients with history of keloid and hypertrophic scars
Patients with history of systemic disease and immunodeficiency
Consumption of anticoagulant drugs
Pregnancy and lactation
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly divided into two groups based on simple randomization method using random digits table. In this method, a collection of non-template numbers is randomly generated and arranged as a table. Even numbers for the intervention group and the odd numbers for the control group are considered. According to the number of patients, they are randomly assigned to one of the intervention or control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are informed about the purpose and method of study. After receiving informed consent, they are blinded to the study groups to unify patients in terms of their empathy sense. Researchers responsible for data collection and analyses will also blinded to the groups allocation for preventing personal viewpoint.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Research deputy, Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-06-15, 1398/03/25
Ethics committee reference number
IR.AJUMS.REC.1398.235
Health conditions studied
1
Description of health condition studied
Scar after Rhinoplasty
ICD-10 code
L76
ICD-10 code description
Intraoperative and postprocedural complications of skin and subcutaneous tissue
Primary outcomes
1
Description
Improvement of scarring in the alar base region
Timepoint
Before and 1 month after treatment
Method of measurement
Vancouver Scar Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One session of laser treatment is performed with Fractional CO2 MORE-XEL -BISON-Korea with radiant characteristics: spot diameter 0.05 mm, pulse duration: 4 ms, laser power 12-14 watts and energy 48-56 mJ per pulse.
Category
Treatment - Devices
2
Description
Control group: There is no intervention for them to treat the scar.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and Maxillofacial Surgery Clinic, Imam Khomeini Hospital, Ahvaz Jundishapur University of Medic
Full name of responsible person
Shahrokh Raisian
Street address
Oral and Maxillofacial Surgery Clinic, Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 0168
Email
raisianshahrokh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi, PhD
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Farzin Hajizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Oral and Maxillofacial Surgery Clinic, Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 0168
Email
hajizadehfarzin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahrokh Raisian
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Oral and Maxillofacial Surgery Clinic, Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 0168
Email
raisianshahrokh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Farzin Hajizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Oral and Maxillofacial Surgery Clinic, Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 0168
Email
hajizadehfarzin@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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