1- Determining the effect of fractional CO2 laser on burn scars based on the patient's age; 2- Determining the effect of fractional CO2 laser on burn scars based on gender; 3- Determining the effect of fractional CO2 laser on burn scar based on scar age; 4- Determining the effect of fractional CO2 laser on burn scar based on the number of laser therapy sessions; 5- Determining the effect of fractional CO2 laser on burn scar based on laser therapy intervals; 6- Determining the effect of fractional CO2 laser on burn scar based on the scar location; 7- Determining the effect of fractional CO2 laser on scar size; 8- Determining the effect of fractional CO2 laser on scar complications
Design
study is before-after and doesn't have randomization.
Settings and conduct
This study will be conducted using the before-after design on patients with thermal burn scar who referred to the clinic in 1403 with a history of hospitalization in the burn ward of Imam Reza Hospital, mashhad. intervention group will be received 1 session laser therapy once a month until the scar score remain unchanged based on the POSAS scale in two consequtive session, and each scar will be measured before and after the intervention by main variables within the study.
Participants/Inclusion and exclusion criteria
1. older than 18 years old
2. Thermal burn injury
3. Symptomatic hypertrophic scar
4. Deep 2nd or 3rd degree mature burn scar
Intervention groups
intervention group consists of people with symptomatic hypertrophic scar caused by deep 2nd or 3rd degree burn with at least 1 year old scar age. This study is before-after and doesn't have control group.
Main outcome variables
Scar complications; patient age; patient gender; scar age; number of laser therapy sessions; scar location; scar size
General information
Reason for update
Acronym
POSAS
IRCT registration information
IRCT registration number:IRCT20240801062613N1
Registration date:2024-08-17, 1403/05/27
Registration timing:registered_while_recruiting
Last update:2024-08-17, 1403/05/27
Update count:0
Registration date
2024-08-17, 1403/05/27
Registrant information
Name
Mehrnaz Zanganeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3620 1043
Email address
mehrnaz.zanganeh@iaumshms.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-17, 1403/05/27
Expected recruitment end date
2025-10-22, 1404/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of fractional Carbon dioxide laser in the treatment of burn scars based on the POSAS score
Public title
Investigating the effect of fractional CO2 laser on burn scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
older than 18 years old
thermal burn
Symptomatic hypertrophic scar with minimal involvement of 20 to 100 cm2
deep second or third degree mature burn scar and injury happened at least 1 year ago
Exclusion criteria:
don't follow the treatment plan continuously
Anticoagulant drug users
Tanning history in the last 2 months
Photo sensitivity history
Pregnancy and breastfeeding
History of keloid scar on skin
Any skin infections
History of using Isotretinoins (Rakuten) in the last 6-12 months
poor control diabetes mellitus
slow wound healing after skin injuries
History of radiation therapy or other rejuvenation methods within the last 6-12 months
inability to stay away from the sunlight due to occupation or lifestyle
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of mashhad medical science islamic azad university
Street address
Imam Khomeini 14 - Bazarche Sarab Alley
City
mashhad
Province
Razavi Khorasan
Postal code
9133736351
Approval date
2024-06-19, 1403/03/30
Ethics committee reference number
IR.IAU.MSHD.REC.1403.023
Health conditions studied
1
Description of health condition studied
hypertrophic burn scar
ICD-10 code
L91.0
ICD-10 code description
Hypertrophic scar
Primary outcomes
1
Description
complications of scar
Timepoint
30 days after laser therapy
Method of measurement
patient-observer scar assessment scale (POSAS)
Secondary outcomes
1
Description
burn stage
Timepoint
before the intervention
Method of measurement
physical examination
Intervention groups
1
Description
fractional co2 laser type is stele laser made in China with 50 watts maximum power, 10 milliseconds time and 0.12 mm spot size. The laser intensity and spot size will be set individually for each patient and based on physical examination. The intervention group will receive 1 session laser therapy once a month until the scar score remains unchanged based on the POSAS scale in two consecutive session, and each scar will be measured before and after the intervention by main variables within the study. Treatment can take up to 2 hours.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Ali Ahmadabadi
Street address
Imam Reza Educational Research and Treatment Center, Imam Reza Hospital Square, Ibn Sina Street
City
mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
emamreza@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Jamshid yousefi
Street address
bazarche sarab alley, Imam khomeini 14
City
mashhad
Province
Razavi Khorasan
Postal code
9133736351
Phone
+98 51 3853 5379
Email
info@iaumshms.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mashhad medical science Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
mehrnaz zanganeh
Position
medical extern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Unit 8, No. 22, Arab Alley 3, Sahid Fallahi 27, Shahid Fallahi Blvd
City
mashhad
Province
Razavi Khorasan
Postal code
9186148434
Phone
+98 51 3620 1043
Email
mehrnaz.zanganeh@iaumshms.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Ahmadabadi
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
3rd floor, Sina doctors building, Ibn Sina corner 7, Doctor's Square
City
mashhad
Province
Razavi Khorasan
Postal code
9137614343
Phone
+98 51 3802 2275
Email
ahmadabadia@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
mehrnaz zanganeh
Position
medical extern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Unit 8, No. 22, Arab Alley 3, Sahid Fallahi 27, Shahid Fallahi Blvd.
City
mashhad
Province
Razavi Khorasan
Postal code
9186148434
Phone
+98 51 3620 1043
Email
mehrnaz.zanganeh@iaumshms.ac.ir
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
data sharing potentially after un-identifing patient's information
When the data will become available and for how long
One year after publishing the results
To whom data/document is available
Academic and scientific researchers only
Under which criteria data/document could be used
The data can be used for scientific research
From where data/document is obtainable
Mehrnaz zanganeh, medical extern
Mehrnaz_zanganeh@yahoo.com
Mehrnaz.zanganeh@iaumshms.ac.ir
What processes are involved for a request to access data/document
After reviewing article by the manager and consultation with the biostatistics specialist, the patient's information will be provided to the applicant with maintaining confidentiality and respecting to patient's privacy