comparing the effect of microneedling by microneedling plus triamcinolone solution in post operation patients scar
Design
15 patients who underwent mammoplasty or abdominoplasty will be selected .6 to 8 weeks after surgery scar will be halved and in one half miconeedling plus placebo and in the other half microneedling plus triamcinolone will be applied.
Settings and conduct
plastic ward of Imam Khomeini Hospital(Tehran)
The scar of the patients will be treated 3 times by 1 month interval.in 3th and 6th month the scars will be evaluated.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 15 patients who underwent surgery in department of plastic surgery of Tehran University.
Exclusion Criteria: Pregnancy .Herpes infection. immune deficiency. dermal infection history. Allergy to steroid or lidocaine-keloid treatment history.
Intervention groups
The patient scar will be halved. in one half microneedling plus triamcinolone solution and in other half microneedling plus placebo will be applied.
Main outcome variables
Vancouver scar scale(VSS)- VAS score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231222060490N1
Registration date:2024-02-10, 1402/11/21
Registration timing:retrospective
Last update:2024-02-10, 1402/11/21
Update count:0
Registration date
2024-02-10, 1402/11/21
Registrant information
Name
Babak Hajipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 914 477 3093
Email address
drhajipourb@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-03, 1402/09/12
Expected recruitment end date
2024-01-03, 1402/10/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of microneedling by microneedling plus Triamcinolone solution in post operation scars
Public title
Comparing the effect of microneedling by microneedling plus Triamcinolone solution in post operation scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Fifteen patients who underwent surgery in department of plastic surgery of Tehran University
Exclusion criteria:
Pregnancy
active herpes infection-
immune deficiency
dermal infections
sensitivity to steroid and lidocaine-
history of keloid treatment in past 1 year
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding, a placebo will be used and it will be provided to the person who performs microneedling, who does not know the content of the drug. The use of placebo and triamcinolone solution will be labeled A and B, and the person who performs microneedling will be on one side of microneedling with Solution A and on the other side, microneedling will be done with drug B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences-Imam Khomeini Hospital
Street address
Plastic surgery ward-11th flour-Mahdi clinic- Imam Khomeini Hospital-Keshavarz Boulevard.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2023-10-10, 1402/07/18
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.342
Health conditions studied
1
Description of health condition studied
surgical scar
ICD-10 code
L90.5
ICD-10 code description
Scar conditions and fibrosis of skin
Primary outcomes
1
Description
Vancouver Scar scale
Timepoint
3th and 6th month
Method of measurement
Scoring scars from 0 to 13 according to four vascular characteristics (zero: normal, one: pink, two: red, three: purple), height/thickness zero: smooth, one: < 2 mm, two: 2-5 mm, three: >5 mm, flexibility) pigmentation (zero: normal, one: hypopigmentation, two: hyperpigmentation), and flexibility (zero: normal, one: flexible, two: surrender, three: firm, four: rope, five: contraction).
2
Description
patient satisfaction(VAS 100)
Timepoint
3th and 6th month
Method of measurement
VAS 100, which is scored by a millimeter scale. In this scale, patients are asked to place a vertical mark on the horizontal axis. mm line indicating their satisfaction with the treatment, where 0 indicates no satisfaction and 100 indicates extreme satisfaction.
Secondary outcomes
empty
Intervention groups
1
Description
There is one group where the wound is divided into two parts and microneedling with triamcinolone solution will be done on one side.
Category
Treatment - Drugs
2
Description
Control group: On the other side of the wound, microneedling will be done with a placebo solution.(Sterile distilled water will be used as a placebo). To the patient and the person performing the procedure, the drug and placebo will be introduced as drug number one and drug number two.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital- Plastic surgery ward
Full name of responsible person
Babak Hajipour
Street address
Plastic surgery ward-11th flour-Mahdi clinic- Imam Khomeini Hospital-Keshavarz Boulevard.Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6118 0000
Email
drhajipourb@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar sari
Street address
Deputy of research, 6th floor, Tehran university central office. Qods steet. Keshavarz Boulevard.
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
there is no financial support from the university
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
Tehran University of Medical Sciences
Full name of responsible person
Babak Hajipour
Position
fellow of plastic surgery
Latest degree
Specialist
Other areas of specialty/work
plastic surgery
Street address
Plastic surgery ward-11th flour-Mahdi clinic- Imam Khomeini Hospital-Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
drhajipourb@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Babak Hajipour
Position
fellow
Latest degree
Specialist
Other areas of specialty/work
plastic surgery
Street address
Plastic surgery ward-11th flour-Mahdi clinic- Imam Khomeini Hospital-Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
drhajipourb@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Babak Hajipour
Position
fellow
Latest degree
Specialist
Other areas of specialty/work
plastic surgery
Street address
Plastic surgery ward-11th flour-Mahdi clinic- Imam Khomeini Hospital-Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
drhajipourb@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no additional information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available