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IRCT20231222060490N1 IRCT 2024-02-10 Tehran University of Medical Sciences Comparing the effect of microneedling by microneedling plus Triamcinolone solution in post operation scars Comparing the effect of microneedling by microneedling plus Triamcinolone solution in post operation scars 2023-12-03 anticipated 15 Complete https://irct.ir/trial/74588 interventional Randomization: N/A, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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. 2 surgical scar. Intervention 1: There is one group where the wound is divided into two parts and microneedling with triamcinolone solution will be done on one side. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is no additional information
public Babak Hajipour
Plastic surgery ward-11th flour-Mahdi clinic- Imam Khomeini Hospital-Keshavarz Boulevard
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6119 0000 drhajipourb@gmail.com Tehran University of Medical Sciences scientific Babak Hajipour
Plastic surgery ward-11th flour-Mahdi clinic- Imam Khomeini Hospital-Keshavarz Boulevard
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6119 0000 drhajipourb@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Fifteen patients who underwent surgery in department of plastic surgery of Tehran University no limit no limit Female Pregnancy active herpes infection- immune deficiency dermal infections sensitivity to steroid and lidocaine- history of keloid treatment in past 1 year L90.5 Scar conditions and fibrosis of skin Treatment - Drugs Treatment - Drugs There is one group where the wound is divided into two parts and microneedling with triamcinolone solution will be done on one side. 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. 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). 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. there is no financial support from the university Approved 2023-10-10 Ethics committee of Tehran University of Medical Sciences-Imam Khomeini Hospital Plastic surgery ward-11th flour-Mahdi clinic- Imam Khomeini Hospital-Keshavarz Boulevard. Tehran Tehran Iran (Islamic Republic of)