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IRCT20250824066966N1 IRCT 2025-09-23 Iran University of Medical Sciences Comparing the results of using a drain and not using a drain in mammoplasty Comparing the results of using a drain and not using a drain in mammoplasty patients with volume reduction of less than 500 cc 2025-09-23 anticipated 13 Recruiting https://irct.ir/trial/85843 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: the randomized block design method will be used. For this purpose, the sample size will be determined based on the online software and then, based on the code obtained from the block design analysis, one of the codes will be randomly selected in the operating room and assigned to the patients. Blocks of four participants will be created and two participants from each group will be placed in each block. Among the codes, one of the methods of using a drain and not using it will be selected for the patient, Blinding description: Postoperatively, patients will be monitored for seroma, hematoma, wound dehiscence, and infection using ultrasound and clinical assessment, and their data will be recorded. The person assessing the outcome and the person analyzing the data are blinded to the use or non-use of drains. 3 Mamoplasty. Intervention 1: Intervention group: They will undergo surgery using the standard superomedial pedicle technique and short scar, and will use drains after surgery. Intervention 2: Control group: They will undergo surgery using the standard superomedial pedicle technique and short scar, and will not using drains after surgery. Yes - There is a plan to make this available What will be shared: A pre-prepared checklist including patient demographic information such as age, gender, volume drained, seroma, hematoma, wound dehiscence rate, healing time, etc. will be performed; all this information will be shared after the study is completed When: One year after publication of the article, the original data will be available for use by other authors To whom: Researchers in the field of plastic surgery inside and outside Iran Conditions: The use of data and documentation is permitted provided the authors' names are mentioned and the article is cited Where to obtain: The author was emailed to obtain the data. d.alaa.aqel@gmail.com How to obtain: First, the author will be sent an email, and after a week, if there is no response, a reminder will be sent, and the author will provide the documentation file to the requester after confirming their identity Comments:
public Alaa Aqel
Yousefabad
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8871 7272 d.alaa.aqel@gmail.com Iran University of Medical Sciences scientific Alaa Aqel
Yousefabad
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8871 7272 d.alaa.aqel@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Undergoing reduction mammaplasty with a resection volume of less than ۵۰۰ cc per breast. Body Mass Index (BMI) between ۱۸ and ۳۰ kg/m² Good general health status (ASA Class I–II) No previous breast surgery No history of breast pathology (e.g., benign or malignant tumors) 18 years 65 years Both Simultaneous performance of other surgical procedures on the breast Resection volume greater than ۵۰۰ cc per breast. History of underlying diseases such as uncontrolled diabetes, heart failure, or renal failure. Active smokers or those with a history of smoking within the past ۶ months History of bleeding disorders or current use of anticoagulant medications Previous history of radiotherapy or surgery involving the breast Presence of active infections or chronic wounds at the time of surgery Inability to comply with postoperative follow-up visits Z42.1 Encounter for breast reconstruction following mastectomy Treatment - Surgery Treatment - Surgery Intervention group: They will undergo surgery using the standard superomedial pedicle technique and short scar, and will use drains after surgery Control group: They will undergo surgery using the standard superomedial pedicle technique and short scar, and will not using drains after surgery Hematoma. Timepoint: Three months after surgery. Method of measurement: Ultrasound. Seroma. Timepoint: Three months after surgery. Method of measurement: Ultrasound. Recovery Time. Timepoint: Three months after surgery. Method of measurement: Days. Wound dehiscence. Timepoint: Three months after surgery. Method of measurement: standard scale (0-2). Infection. Timepoint: Three months after surgery. Method of measurement: Observation. Iran University of Medical Sciences Approved 2025-08-13 Ethics committee of Iran University of Medical Sciences Hemmat highway Tehran Tehran Iran (Islamic Republic of)