The effect of photodynamic therapy using methylene blue and micro-needling on patient satisfaction and improvement of scar keloid and hypertrophic after surgery in patients with at least two scars
Determining the effect of photodynamic therapy using methylene blue and microneedling on patient satisfaction and improving keloid and hypertrophic scars after surgery in patients with at least two scars.
Design
double-blinded, randomized clinical trial
Settings and conduct
Research in plastic surgery will be conducted using a double-blind clinical trial on patients with at least two scars after surgery in a clinic in Hamedan.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with scars after surgery
Patients with at least two scars
Patients with keloid and hypertrophic scars.
At least four months after the surgery
The possibility of phone and in-person access during the research and six months after the end of treatment
Age over five years
Exclusion criteria:
Patients' lack of consent to participate in the research
Coagulopathy and use of anticoagulants
The presence of fungal skin diseases
Active skin infection
Patients with a scar
Patients with malignancy in other parts of the body
Patients with possible scar malignancy
active acne
Herpes labialis or any other local infection such as warts
Moderate to severe chronic skin diseases such as eczema and psoriasis
Patients undergoing chemotherapy/radiotherapy.
Failure to visit the relevant doctor's clinic on the specified date
Intervention groups
Patients with keloid scars treated with photodynamic therapy with micro-needling using 1% methylene blue
Patients with keloid scars treated with photodynamic therapy with micro-needling using methylene blue
0.1 percent
Patients with hypertrophic scars are treated with photodynamic therapy with microneedling using 1% methylene blue.
Patients with hypertrophic scars treated with photodynamic therapy with micro-needling using methylene blue 0.1%
Main outcome variables
Improving the treatment of patients with keloid and hypertrophic scars.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240409061456N1
Registration date:2024-04-17, 1403/01/29
Registration timing:prospective
Last update:2024-04-17, 1403/01/29
Update count:0
Registration date
2024-04-17, 1403/01/29
Registrant information
Name
Mahshid Sabet ghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3323 3063
Email address
ma.sabetghadam@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of photodynamic therapy using methylene blue and micro-needling on patient satisfaction and improvement of scar keloid and hypertrophic after surgery in patients with at least two scars
Public title
The effect of photodynamic therapy using methylene blue and micro-needling on patient satisfaction and improvement of scar keloid and hypertrophic after surgery in patients with at least two scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with scars after surgery
Patients with at least two scars
Patients with keloid and hypertrophic scars after surgery
At least 4 months have passed since surgery
The possibility of telephone and in-person access during the research and 6 months after the end of treatment
Age over 5 years
Exclusion criteria:
Patients' lack of consent to participate in the research
Coagulopathy and use of anticoagulants
The presence of fungal skin diseases
Active skin infection
Patients with one scar
Patients with malignancy in other parts of the body
Patients with possible scar malignancy
active acne
Herpes labialis or any other local infection such as warts
Moderate to severe chronic skin disease such as eczema and psoriasis
Patients undergoing chemotherapy/radiotherapy.
Failure to visit the relevant doctor's clinic on the specified date
Age
From 5 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a double-blind type, meaning it blinds both the patients who received methylene blue concentration for each of the scars and the person who performs the statistical analysis, who is unaware of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind type, meaning it blinds both the patients who received methylene blue concentration for each of the scars and the person who performs the statistical analysis, unaware of the groups.
Placebo
Not used
Assignment
Other
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
Padegan Ave Rajaee hospital
City
Qazvin
Province
Qazvin
Postal code
3418656818
Approval date
2024-03-10, 1402/12/20
Ethics committee reference number
IR.UMSHA.REC.1402.767
Health conditions studied
1
Description of health condition studied
Hypertrophic scar and keloid
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determining the type of scar using the "Japan Workshop Scale" questionnaire
Timepoint
first visit
Method of measurement
Japan Workshop Scale
2
Description
Determining the average improvement of hypertrophic scar using phototherapy and micro-needling in 1% and 0.1% methylene blue concentration
Timepoint
14 days, 45 days, 3 months and 6 months after the last treatment session
Method of measurement
Observer patient scale and Japanese workshop scale
3
Description
Determining the average improvement of keloid scar using phototherapy and micro-needling in 1% and 0.1% methylene blue concentration
Timepoint
14 days, 45 days, 3 months and 6 months after the last treatment session
Method of measurement
Observer patient scale and Japanese workshop scale
4
Description
Determining the average patient satisfaction in the hypertrophic scar group using light therapy and micro-needling in the concentration of 1% and 0.1% methylene blue
Timepoint
14 days, 45 days, 3 months and 6 months after the last treatment session
Method of measurement
Observer patient scale and Japanese workshop scale
5
Description
Determining the average patient satisfaction in the keloid scar group using light therapy and micro-needling in the concentration of 1% and 0.1% methylene blue
Timepoint
14 days, 45 days, 3 months and 6 months after the last treatment session
Method of measurement
Observer patient scale and Japanese workshop scale
Secondary outcomes
1
Description
Determining the average recovery of hardness score in the keloid group receiving methylene blue 1% and 0.1%
Timepoint
14 days, 45 days, three months, and six months after the last treatment session
Method of measurement
patient-observer scale and Japanese workshop scale
2
Description
Determining the average recovery of scars hardness score in the hypertrophic group receiving methylene blue 1% and 0.1%
Timepoint
14 days, 45 days, three months, and six months after the last treatment session
Method of measurement
patient-observer scale and Japanese workshop scale
3
Description
Determining the average recovery score of scar height in the keloid group receiving methylene blue 1% and 0.1%
Timepoint
14 days, 45 days, three months, and six months after the last treatment session
Method of measurement
patient-observer scale and Japanese workshop scale
4
Description
Determining the average recovery of the scar height score in the hypertrophic group receiving methylene blue 1% and 0.1%
Timepoint
14 days, 45 days, three months, and six months after the last treatment session
Method of measurement
patient-observer scale and Japanese workshop scale
5
Description
Determining the average improvement of scar redness score in the keloid group receiving methylene blue 1% and 0.1%
Timepoint
14 days, 45 days, three months, and six months after the last treatment session
Method of measurement
patient-observer scale and Japanese workshop scale
6
Description
Determining the average improvement of scar redness score in the hypertrophic group receiving methylene blue 1% and 0.1%
Timepoint
14 days, 45 days, three months, and six months after the last treatment session
Method of measurement
patient-observer scale and Japanese workshop scale
7
Description
Determining the average improvement of itching score in the keloid group receiving methylene blue 1% and 0.1%
Timepoint
14 days, 45 days, three months, and six months after the last treatment session
Method of measurement
patient-observer scale and Japanese workshop scale
8
Description
Determining the average recovery of itching score in the hypertrophic group receiving methylene blue 1% and 0.1%
Timepoint
14 days, 45 days, three months, and six months after the last treatment session
Method of measurement
patient-observer scale and Japanese workshop scale
9
Description
Determining the average improvement of the pain score in the keloid group receiving methylene blue 1% and 0.1%
Timepoint
14 days, 45 days, three months, and six months after the last treatment session
Method of measurement
patient-observer scale and Japanese workshop scale
10
Description
Determining the average improvement of the pain score in the hypertrophic group receiving methylene blue 1% and 0.1%
Timepoint
14 days, 45 days, three months, and six months after the last treatment session
Method of measurement
patient-observer scale and Japanese workshop scale
Intervention groups
1
Description
Intervention group: Patients with keloid scars receiving micro-needling and light therapy with 1% concentration of methylene blue
Category
Treatment - Other
2
Description
Intervention group: patients with hypertrophic scars receiving micro-needling and phototherapy with 1% concentration of methylene blue.
Category
Treatment - Other
3
Description
Intervention group: patients with keloid scars receiving micro-needling and light therapy with 0.1% concentration of methylene blue.
Category
Treatment - Other
4
Description
Intervention group: patients with hypertrophic scars receiving micro-needling and light therapy with a concentration of 0.1% methylene blue.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
clinic
Full name of responsible person
Mahshid Sabet ghadam
Street address
Pastor
City
Hamedan
Province
Hamadan
Postal code
3418656818
Phone
+98 28 3323 3063
Email
Mahshid.68.hajar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
DR.Behzad imani
Street address
Shahid Fahmide
City
Hamedan
Province
Hamadan
Postal code
3418656818
Phone
+98 28 3323 3063
Email
Mahshid.68.hajar@gmail.com
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
Mahshid Sabet Ghadam
Position
Student
Latest degree
Master
Other areas of specialty/work
Operating Room
Street address
Malek Abad
City
Qazvin
Province
Hamadan
Postal code
3418656818
Phone
+98 28 3323 3063
Email
ort.mahshid@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
DR.Zahra Farahani Nik
Position
Plastic and Reconstructive Surgeon
Latest degree
Subspecialist
Other areas of specialty/work
Plastic and Reconstructive Surgery
Street address
Padegan
City
Qazvin
Province
Qazvin
Postal code
3418656818
Phone
+98 28 3323 3063
Email
Dr.zfarahaninik@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahshid Sabet Ghadam
Position
Student
Latest degree
Master
Other areas of specialty/work
Operating Room
Street address
Malek Abad
City
Qazvin
Province
Qazvin
Postal code
3418656818
Phone
+98 28 3323 3063
Email
ort.mahshid@gmail.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
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 the information related to the primary and secondary outcomes of the studied people will be made available in the form of an article while preserving the patient's privacy. Data analysis will be done using SPSS software.
When the data will become available and for how long
After completing the study and analyzing the data
To whom data/document is available
Researchers working in academic centers.
Under which criteria data/document could be used
Other people can access part of the information upon request from the Corresponding author.
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document
Researchers can request information by sending a request to the Corresponding author's email.