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IRCT20220619055220N1 IRCT 2022-06-30 Kerman University of Medical Sciences Comparison of the results of using a drain or not using it in forearm fractures Comparison of the Postoperative Results, and complications of Both-bone Forearm Fractures Surgery with or without suction Drainages in 15 to 65 y/o patients 2022-07-23 anticipated 44 Complete https://irct.ir/trial/64293 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of patients will be done using quadruple random blocks, considering that the number of treatment methods is two methods (randomly one method is called A and the other method B). Possible blocks are AABB, ABAB, ABBA, BAAB, BABA and BBAA are.These blocks are also randomly selected and assigned to each method based on the sequence created by the patients, Blinding description: In this study, blinding is performed on the data analyzer. N/A Forearm both bone fractures. After confirmation of the fracture using AP and lateral radiographs of the forearm, elbow and wrist, patients in the operating room will undergo volar henry aproach to fix the radius bone and lateral approach to fix the ulna bone with screws and plates. After he surgery will be completed in one In one group of patients, a hemovac drain will be inserted into the wound, and in the other group,after complete hemostasis the drain will not be implanted. All surgeries will be performed by a surgeon and surgical assistant (study researchers) in one operating room.. Yes - There is a plan to make this available What will be shared: All tests and measured patient variables will be available after the patients' personal information is not identifiable. When: After gathering complete and documented information To whom: For researchers in medical centers Conditions: Requested data according to the approvals of the Medical Ethics Committee Where to obtain: Medical ethics references of medical sciences How to obtain: Refer to Medical Ethics Center of Medical Sciences Comments:
public dramirreza sadeghifar
shahid bahonar hospital,kerman
kerman Iran (Islamic Republic of) 7613747181 0098 32237115 drsadeghifar2000@gmail.com Kerman University of Medical Sciences scientific دکتر امیررضا صادقی فر
shahid bahonar hospital,kerman
kerman Iran (Islamic Republic of) 7613747181 00 3432237115 drsadeghifar2000@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Fractures of the forearm bone between the ages of 15 and 65 that require open reduction and internal fixation 15 years 65 years Both Open fractures as well as patients who have fractures in other organs Treatment - Surgery After confirmation of the fracture using AP and lateral radiographs of the forearm, elbow and wrist, patients in the operating room will undergo volar henry aproach to fix the radius bone and lateral approach to fix the ulna bone with screws and plates. After he surgery will be completed in one In one group of patients, a hemovac drain will be inserted into the wound, and in the other group,after complete hemostasis the drain will not be implanted. All surgeries will be performed by a surgeon and surgical assistant (study researchers) in one operating room. The rate of infection and union of the forearm bones. Timepoint: During the first 48 hours, 2 weeks later, 6 weeks later, 3 months later and 6 months after surgery. Method of measurement: Patients' hemoglobin level before and after surgery using cbc test/Evaluation of patients' pain through visual analog score. Comparison of patients' pain during 48 hours after surgery/Comparison of hemoglobin loss in two groups/Comparison of patients' pain based on visual analog scale/Comparison of bone union in two groups. Timepoint: During the first 48 hours, 2 weeks later, 6 weeks later, 3 months later and 6 months later. Method of measurement: CBC-based hemoglobin measurement of patients/The amount of discharge from the hemovac drain. Kerman University of Medical Sciences Approved 2022-06-18 Ethics committee of kerman University of Medical Sciences shahid bahonar hospital,kerman kerman Kerman Iran (Islamic Republic of)