The aim of this study is to Compare the Microneedeling Therapeutic Effect versus Fractional CO2 Laser in the Treatment of Burn Scars in burn patients referred to Rasoul e Akram Hospital.
Design
In this clinical trial study, 56 patients with burn scars who are referred to Rasoul-e-Akram Hospital are selected.Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
In this research, 56 patients with burn scars who are referred to Rasoul-e-Akram Hospital were randomly divided into two control and intervention groups.A intervention group is treated with microneedeling in three sessions at intervals of 4 to 6 weeks and is followed up 3 months after the last session and a control group is treated with co2 fractional laser in three sessions at intervals of 4 to 6 weeks and is followed up 3 months after the last session.
Participants/Inclusion and exclusion criteria
Inclusion criteria: second and third degree burns; the age range is between 15 and 50 years old; lack of previous treatment procedures at the burning scar. Exclusion criteria: burns with higher grades; skin scars other than burns; symptoms of skin infection in affected areas; intolerance to each of the therapeutic interventions.
Intervention groups
A intervention group is treated with microneedeling in three sessions at intervals of 4 to 6 weeks and is followed up 3 months after the last session and a control group is treated with co2 fractional laser in three sessions at intervals of 4 to 6 weeks and is followed up 3 months after the last session.
Main outcome variables
Primary outcomes include: Contracture; hieght; Color; pliability; Vascularity assessed by the Vancouver burn scar assessment scale (VSS) and Patients' satisfaction level is assessed by the visual analogue scale (VAS) as a secondary outcome.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140624018210N6
Registration date:2018-01-13, 1396/10/23
Registration timing:registered_while_recruiting
Last update:2018-01-13, 1396/10/23
Update count:0
Registration date
2018-01-13, 1396/10/23
Registrant information
Name
Elham Behrangi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 2040
Email address
behrangi.e@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran university of medical sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Microneedeling Therapeutic Effect versus Fractional CO2 Laser in the Treatment of Burn Scars in Patients with Burn
Public title
Comparison of Microneedeling Therapeutic Effect versus Fractional CO2 Laser in the Treatment of Burn Scars in Patients with Burn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Second and third degree burns
The age range is between 15 and 50 years old
Lack of previous treatment procedures at the burning scar
Exclusion criteria:
Burns with higher grades
Skin scars other than burns
Symptoms of skin infection in affected areas
Intolerance to each of the therapeutic interventions
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
56
More than 1 sample in each individual
Number of samples in each individual:
2
In each participant, the burn scar is divided into 2 parts, and one part is treated with microneedeling and one part is treated with a co2 fractional laser.
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization is a commonly used technique in clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms. This method increases the probability that each arm will contain an equal number of individuals by sequencing participant assignments by block.The randomization unit is individual and randomization's tool is a statistical software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the Outcome assessor and data analyzer has been blinded. The Outcome assessor is people who are responsible for making assessments on outcomes or gathering data on outcome variables and does not know which treatment is performed on the burned scar. Data analyser is people who analyse the data collected during a trial and they do not know how to treat the participants.
Placebo
Not used
Assignment
Parallel
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
Iran University of Medical Sciences, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-04-08, 1396/01/19
Ethics committee reference number
IR.IUMS.REC 1395.9411166003
Health conditions studied
1
Description of health condition studied
Burn scar
ICD-10 code
S00-T98
ICD-10 code description
injury, poisoning and certain other consequences of external causes
Primary outcomes
1
Description
Contracture
Timepoint
Before intervention, every 4 to 6 weeks for 3 session, three months after the last intervention
Method of measurement
Photography, clinical assesment
2
Description
Height
Timepoint
Before intervention, every 4 to 6 weeks for 3 session, three months after the last intervention
Method of measurement
VSS scoring scale
3
Description
Color
Timepoint
Before intervention, every 4 to 6 weeks for 3 session, three months after the last intervention
Method of measurement
VSS scoring scale
4
Description
Pliability
Timepoint
Before intervention, every 4 to 6 weeks for 3 session, three months after the last intervention
Method of measurement
VSS scoring scale
5
Description
Vascularity
Timepoint
Before intervention, every 4 to 6 weeks for 3 session, three months after the last intervention
Method of measurement
VSS scoring scale
Secondary outcomes
1
Description
Patient satisfaction
Timepoint
Before intervention, every 4 to 6 weeks for 3 session, three months after the last intervention
Method of measurement
Photography, VAS scale
Intervention groups
1
Description
Intervention group: use of microneedeling, three sessions at intervals of 4 to 6 weeks
Category
Treatment - Other
2
Description
Control group: use of fractional co2 laser, three sessions at intervals of 4 to 6 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasoul Akram Hospital
Full name of responsible person
Dr Mahrokh Fotooei
Street address
Hazrat Rasoul Akram Hospital, Niayesh street, Sattarkhan avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1313114456
Phone
+98 21 6435 2378
Email
mahrokh.fotooei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mehrdad Eftekhar
Street address
Iran University of Medical Sciences, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8860 2230
Email
mehrdad.eftekhar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?