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IRCT20111121008146N29 IRCT 2018-01-21 Shahid Beheshti University of Medical Sciences The effect of subcision on acne scar Evaluation of Efficacy of BBSB type C in comparison with needle subcision on atrophic acne scar 2017-02-19 anticipated 32 Complete https://irct.ir/trial/28717 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patient's face are divided into two intervention groups 1 and 2 according to a simple randomized 1: 1 random number table. The analyst and the patient are not aware of the groups, Blinding description: The group and side of the face are placed in pairs and in dark envelopes. It is available to the surgeon and only the surgeon is informed of the patient's healing side. Procedures in this project are done by a skilled dermatologist. The envelope will be opened by a physician only after initial evaluations in each person, and neither patients nor analysts will be aware of the groups. N/A Atrophic acne scar. Intervention 1: Intervention group1:The A side is required to be subcision to BBSB type C. The site of the entry of the subcision blade is at a point in the 1 cm front and 2 cm ahead of the ear tragus. Iodine is used to sterilize the area. Tomsent solution is combined with 50 cc of lidocaine, 1% pure, 1 cc epinephrine, 0.1% and 10 cc of sodium bicarbonate solution, 4.2% in normal saline 1 liter for local anesthetic. 50 to 100 cc of this solution is injected in a sub-dermal plaque with gauge 23 needle at 4 to 7 dots. For subcision, BBSB type C is used. Through the inlet area that has already been identified and numb, the blade number C is entered on the parallel plan with the skin on the subdermal plate and the smooth surface of the blade is facing up (the index of the thumb is on the handle to indicate it ) All fibrous bands are released by moving forward and backward, and by moving the pseudo-fan, the blade is moved to the adjacent portions. The blade is moved slowly to avoid excessive force and damage to the nerves and vessels and to the skin. Also, the lack of movement of the blade to the lateral will also help prevent this damage. About two-thirds of the length of the blade can be entered into the skin and used from an entrance area for the entire scar area of ​​the face side. After the procedure, an antibiotic with an without pressure gas for simple dressing is used. Oral antibiotics or anti-viral antibiotics are prescribed according to individual needs. Patients are educated about the possibility of edema, bruising, mild thrombosis in the first few days. Patients are advised to sleep semi sitting for two nights to reduce swelling. Intervention 2: Intervention group2: On the B side, perform the subcision with the needle number 22. After determining the range and location of atrophic scars with non-toxic surgical markers, the range is averaged by about 10 cc of lidocaine-2% pure without epinephrine. For subcision, 22-gauge needles are used for deep-scarves and 27-gauge scarves for surface scars attached to a 1-cc syringe. The skin of the patient is pinched or stretched by a non surreptitious surgeon to make the skin firm and non-moving. By inserting the needle from the proximal axial atrophic scar, the fibrous bands are released by forward movement and lateral movement in parallel planes of the skin and in the scars area and about 1 mm from the margin. For each atrophic scar, at least one entry point and sometimes a needle insertion area are required. The ultimate goal is to move the needle from the horizontal to the lateral, along with a mild hematoma in the atrophic scar region and a swelling in the surface of the scar. Hemostasis is done by placing a non-pressure gas in the area. The maximum number of atrophic scars in the patient's range will be treated on that side. After the procedure, an antibiotic with an without pressure gas for simple dressing is used. Oral antibiotics or anti-viral antibiotics are prescribed according to individual needs. Patients are educated about the possibility of edema, bruising, mild thrombosis in the first few days. Patients are advised to sleep semi sitting for two nights to reduce swelling. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Not enough time
public Dr Behrouz Barikbin
Shohadaye Tajrish Hospital, Tajrish, Tehran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2274 9221 laser.cntr@yahoo.com Shahid Beheshti University of Medical Sciences scientific Dr Behrouz Barikbin
Shohadaye Tajrish Hospital, Tajrish, Tehran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2274 9221 laser.cntr@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 18 to 50 years old Patient's complete consent to participate in the study Acne atrophic scars on both sides of the species with a relatively uniform intensity on both sides 18 years 50 years Both Active nodulosistic acne (more than 6 papules or nodules on each side of the face) Active skin infection ( herpes simplex or jaundice infection) Hematological disorders or coagulopathy Immunosuppression Dermatological diseases interfere with the procedure Previous biography of colloids Taking medications that prolong the bleeding time (especially aspirin, warfarin or vitamin E) Isotretinoin intake over the past 12 months Performing resurfacing procedures over the past 6 months include dermabrasion, laser therapy, chemical peeling Pregnancy or breastfeeding L99 Other disorders of skin and subcutaneous tissue in diseases classified elsewhere Treatment - Devices Treatment - Devices Intervention group1:The A side is required to be subcision to BBSB type C. The site of the entry of the subcision blade is at a point in the 1 cm front and 2 cm ahead of the ear tragus. Iodine is used to sterilize the area. Tomsent solution is combined with 50 cc of lidocaine, 1% pure, 1 cc epinephrine, 0.1% and 10 cc of sodium bicarbonate solution, 4.2% in normal saline 1 liter for local anesthetic. 50 to 100 cc of this solution is injected in a sub-dermal plaque with gauge 23 needle at 4 to 7 dots. For subcision, BBSB type C is used. Through the inlet area that has already been identified and numb, the blade number C is entered on the parallel plan with the skin on the subdermal plate and the smooth surface of the blade is facing up (the index of the thumb is on the handle to indicate it ) All fibrous bands are released by moving forward and backward, and by moving the pseudo-fan, the blade is moved to the adjacent portions. The blade is moved slowly to avoid excessive force and damage to the nerves and vessels and to the skin. Also, the lack of movement of the blade to the lateral will also help prevent this damage. About two-thirds of the length of the blade can be entered into the skin and used from an entrance area for the entire scar area of ​​the face side. After the procedure, an antibiotic with an without pressure gas for simple dressing is used. Oral antibiotics or anti-viral antibiotics are prescribed according to individual needs. Patients are educated about the possibility of edema, bruising, mild thrombosis in the first few days. Patients are advised to sleep semi sitting for two nights to reduce swelling. Intervention group2: On the B side, perform the subcision with the needle number 22. After determining the range and location of atrophic scars with non-toxic surgical markers, the range is averaged by about 10 cc of lidocaine-2% pure without epinephrine. For subcision, 22-gauge needles are used for deep-scarves and 27-gauge scarves for surface scars attached to a 1-cc syringe. The skin of the patient is pinched or stretched by a non surreptitious surgeon to make the skin firm and non-moving. By inserting the needle from the proximal axial atrophic scar, the fibrous bands are released by forward movement and lateral movement in parallel planes of the skin and in the scars area and about 1 mm from the margin. For each atrophic scar, at least one entry point and sometimes a needle insertion area are required. The ultimate goal is to move the needle from the horizontal to the lateral, along with a mild hematoma in the atrophic scar region and a swelling in the surface of the scar. Hemostasis is done by placing a non-pressure gas in the area. The maximum number of atrophic scars in the patient's range will be treated on that side. After the procedure, an antibiotic with an without pressure gas for simple dressing is used. Oral antibiotics or anti-viral antibiotics are prescribed according to individual needs. Patients are educated about the possibility of edema, bruising, mild thrombosis in the first few days. Patients are advised to sleep semi sitting for two nights to reduce swelling. Severity of atrophic scars. Timepoint: Before starting treatment, in the first week after treatment, the first month, the third month and the sixth month after treatment. Method of measurement: Visual Analogue Scale. Shahid Beheshti University of Medical Sciences Approved 2017-02-05 Ethics committee of Shahid Beheshti University of Medical Sciences Next to Ayatollah Taleghani Hospital, Shahid Arabi ST. Yemen street, Shahid Chamran highway, Tehran Tehran Tehran Iran (Islamic Republic of)