Evaluation of the efficacy and safety of co2 fractional laser in combination with Pulsed dye laser vs. each one alone in treatment of hypertrophic burn scars: a blinded RCT
The main purpose: Comparing scar Improvements (total VSS score, color, vessels, flexibility) between three groups co2 fractional laser, Pulsed-Dye Laser (PDL) and co2 fractional laser plus PDL.
Secondary purpose: Comparing patient satisfaction between the three groups
Design
A three-arm parallel group randomized trial with blinded secondary assessor.
Settings and conduct
The main performer (Dr. Goodarzi) performs the treatment with fractional co2 and PDL lasers.
All volunteers will receive written consent and all patients who will be included in the study will receive accurate and high-quality imaging of their scars before receiving any treatment and 40 days after the last treatment.
Evaluation of the results of interventions performed by a secondary assessor who is a dermatologist (Dr. Rouhani) and this study is blind on his behalf.
Participants/Inclusion and exclusion criteria
Women who are included in the study should not breastfeed; should not be pregnant.
Study participants should not have used lasers for the past 1 month; should not have used topical or injectable corticosteroids in the past 1 month
; shouldn't have underlying diseases that interfere with the healing process of the scar; Like diabetes
Intervention groups
Patients with hypertrophic burn scars are divided into three groups:
Group 1: PDL lasers are performed in one treatment session and repeated for up to 3 sessions.
Group 2: Fractional CO2 lasers are performed in one treatment session and repeated up to 3 sessions.
Group 3: Combination therapy includes one PDL laser and one fractional co2 laser, both of which are performed in one treatment session and repeated for up to 3 sessions.
Main outcome variables
1. Effectiveness in terms of scar improvement according to Vancouver Scar Scale (VSS) score
2. Safety is evaluated according to long-lasting complications.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201005048928N1
Registration date:2022-07-05, 1401/04/14
Registration timing:retrospective
Last update:2022-07-05, 1401/04/14
Update count:0
Registration date
2022-07-05, 1401/04/14
Registrant information
Name
maedeh Karimi Kivi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 4375
Email address
maedeh.karimi100@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-27, 1399/12/09
Expected recruitment end date
2021-05-09, 1400/02/19
Actual recruitment start date
2021-02-27, 1399/12/09
Actual recruitment end date
2022-07-01, 1401/04/10
Trial completion date
2022-07-01, 1401/04/10
Scientific title
Evaluation of the efficacy and safety of co2 fractional laser in combination with Pulsed dye laser vs. each one alone in treatment of hypertrophic burn scars: a blinded RCT
Public title
Evaluation of the effect and safety of fractional PDL and CO2 lasers on burn scars
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with hypertrophic scars caused by burn
Exclusion criteria:
Women who are included in the study should not breastfeed
Women who are included in the study should not be pregnant
Study participants should not have used lasers for the past 1 month.
Study participants should not have used topical or injectable corticosteroids in the past 1 month
ُStudy participants shouldn't have underlying diseases that interfere with the healing process of the scar; Like diabetes
Age
From 10 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
3
بسته به میزان وسعت سوختگی در بیماران، از بعضی از آنان بیش از یک نمونه گرفته شده .است
Actual sample size reached:
55
More than 1 sample in each individual
Actual sample size in each individual:
3
بسته به میزان وسعت سوختگی در بیماران، از بعضی از آنان بیش از یک نمونه گرفته شده .است
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is to prepare a random list in the form of random blocks with a volume of 60 that patients are divided into three groups (2 intervention groups and a control group).
The random list will be generated by the statistician of the project and will be provided directly to the main executor of the project. It should be noted that the patient randomization list is prepared by NCSS PASS11. Using the Procedures menu, the DOE submenu and select the desired method in the Randomization list will be done.
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study is a clinical trial study with three arms and one blind side. The main performer (Dr. Godarzi) performs the treatment for patients with fractional co2 lasers or PDL lasers or a combination of both treatments depending on the group of patients in which the patient is placed. The results of the interventions are evaluated by a secondary assessor who is a dermatologist (Dr. Rouhani) and she is blind in this study.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Highway between Chamran and Sheikh Fazlollah, Iran University of Medical Sciences, 5th Floor
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-09-22, 1399/07/01
Ethics committee reference number
IR.IUMS.FMD.REC.1399.411
Health conditions studied
1
Description of health condition studied
treatment of hypertrophic or keloidal burn scars
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Effectiveness of co2 laser fractional + PDL laser vs each one alone in terms of scar improvement
Timepoint
Before starting treatment, 40 days after the last treatment session
Method of measurement
Due to the Total Vancouver Scar Scale, color of the scar, vascular distribution of the scar, flexibility of the scar, height of the scar
2
Description
CO2 fractional laser + PDL safety in comparison with each alone in terms of scar improvement
Timepoint
40 days after the last treatment session
Method of measurement
Prolonged pain or burning, prolonged redness or erythema, post-inflammatory hyperpigmentation (PIH) and even laser site infection
Secondary outcomes
1
Description
Patient's satisfaction with the outcome of treatment
Timepoint
40 days after the last visit
Method of measurement
questionnaire
Intervention groups
1
Description
Control group: Patients in the control group receive a PDL laser with a pulse of 595 nm in first treatment session and this treatment is repeated for up to 3 sessions. The interval between treatment sessions is about 1 month. PDL is performed using the Synchro VasQ laser device, which is made in Italy for deka Alexandrite Company. The device settings are as follows:pulse= 595 nm, power=6.5 J/cm², single duration=0.5 ms , spot size=7mm
Category
Treatment - Other
2
Description
Intervention group 1: Fractional CO2 lasers are performed in first treatment session and repeated up to 3 sessions. The interval between treatment sessions is about 1 month. Fractional Co2 is made using the smartxide2 DOT / RF, both of which are made in Italy for deka Alexandrite. The device settings are as follows: Co2 fractional laser: fractional power =12 J/cm², pulse= 10600 nm, Stack=2 , DT(dwelling time)=800 ms , space=800mm
Category
Treatment - Other
3
Description
Intervention group 2: Combination therapy includes a PDL laser and a fractional co2 laser, both of which are performed in first treatment session and repeated up to 3 sessions. The interval between treatment sessions is about 1 month. PDL is performed using a Synchro VasQ laser and Co2 fractional laser using a smartxide2 DOT / RF device, both of which are made for Deka Alexandria, Italy. The device settings are as follows: Co2 fractional laser: fractional power =12 J/cm² pulse= 10600 nm, Stack=2 , DT(dwelling time)=800 ms , space=800mm² PDL: pulse= 595 nm, power=6.5 J/cm², single duration=0.5 ms , spot size=7mm
5th Floor, Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Fax
+98 21 8662 2703
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Maedeh Karimi Kivi
Position
intern of medcine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Unite 4th., NO. 20, East sixth AV., North Allameh street., Saadat Abad
City
Tehran
Province
Tehran
Postal code
1997856418
Phone
+98 21 2207 4375
Email
maedeh.karimi100@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azadeh Goodarzi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Corner of Mansouri Street., Niayesh St., Sattarkhan., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
021-64351
Email
goodarzi.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maedeh Karimi Kivi
Position
Internship (medcine)
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
N.20, East 16th street, North Allameh Tabataie, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1997856418
Phone
+98 21 2207 4375
Fax
Email
maedeh.karimi100@yahoo.com
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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Potential data is sharing after making people undetectable
When the data will become available and for how long
One year after the results have been published
To whom data/document is available
only for academic and scientific researchers
Under which criteria data/document could be used
The data can be used for scientific researches .
From where data/document is obtainable
Maedeh Karimi Kivi, medical student, maedeh.karimi100@yahoo.com
What processes are involved for a request to access data/document
After reviewing by the project executor and in consultation with the biostatistics specialist and by keeping the patients' information confidential, the applicant will be provided.