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IRCT20230425057988N1 IRCT 2023-06-06 Iran University of Medical Sciences Results of reduction mammoplasty in two different pedicle surgical methods The results of reduction mammoplasty in two superior and medial methods and their comparison 2023-05-05 anticipated 32 Complete https://irct.ir/trial/69753 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by blocks method. For this purpose, blocks of four are prepared, the name of the intervention is written on two papers and the name of the comparison is written on the other two papers. The researcher knows that the intervention group is medial and the comparison group is superior. The papers are piled up and placed in the envelope, and one paper is pulled out for each patient. Then four papers are not returned to the envelope and this process is repeated until the sample volume is reached, Blinding description: One strain is blinded and the data and outcome assessor who records sensory results and other criteria after and before surgery is unaware of the type of surgery. N/A Reduction Mammoplasty. Intervention 1: Intervention group: In superior method surgery, we remove the skin in the superior pedicle area without touching the other parts and remove the skin from that area, and after the superior epithelialization, the skin is sutured. Intervention 2: Control group: In medial surgery, the medial part is cut, and after tissue and fat removal, the skin is epithelialized and sutured at the incision site. Yes - There is a plan to make this available What will be shared: The data file of the patients and their characteristics will be made available to others if needed by the researchers by sending a request email, completely maintaining the confidentiality and non-identification of the individuals by assigning a code to each of them. When: It will be possible to access the consent form and patient information through the e-mail of the researcher and up to 1 year after the study. f.karami272@gmail.com To whom: Researchers and researchers in the field of plastic surgery in universities of medical sciences inside and outside the country Conditions: In the case of ideas and examination of existing knowledge gaps in this subject, as well as modeling the implementation method and sub-goals of the research Where to obtain: To receive documents, send a message to the author's email. f.karami272@gmail.com How to obtain: Documents will be sent to applicants within 1 week after the email Comments:
public Farzaneh Karami
Seyed Jamalodin Asadabdi
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8871 7272 f.karami272@gmail.com Iran University of Medical Sciences scientific Abolfazl Abbaszadeh
Seyed Jamalodin Asadabadi St.
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8871 7272 daa200028@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Candidates for reduction mammoplasty Women between 30 and 60 years old Obtaining informed consent from patients 30 years 60 years Female Patients who have already had breast surgery Patients with underlying or neurological diseases Patients with breast cancer Z41.1 Encounter for cosmetic surgery Treatment - Surgery Treatment - Surgery Intervention group: In superior method surgery, we remove the skin in the superior pedicle area without touching the other parts and remove the skin from that area, and after the superior epithelialization, the skin is sutured Control group: In medial surgery, the medial part is cut, and after tissue and fat removal, the skin is epithelialized and sutured at the incision site میزان حساسیت. Timepoint: Before surgery and after surgery in the first, third and sixth month. Method of measurement: Using monofilament kit and tow point discrimination test method. In the monofilament method, this sensory test is performed by an evaluator in a standard way. Seven points on the chest are tested. These areas include one point in each quadrant (points 1 to 4), one point on the upper pole of the areola (point 5), one point on the lower pole of the areola (point 6), and one point on the nipple (point 7). Scar status. Timepoint: One, three and six months after surgery. Method of measurement: Observing the absence of infection or swelling and redness at the scar site. Blood supply status. Timepoint: One, three and six months after surgery. Method of measurement: Observing the condition of blood supply and lack of tissue necrosis and change of skin color to indigo or dark nipple based on clinic clinical examinations. Hazrate Fatemeh Hospital Approved 2023-04-19 Ethics committee of Iran University of Medical Sciences Hemmat Highway Tehran Tehran Iran (Islamic Republic of)