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IRCT20211201053235N3 IRCT 2022-04-15 Shahid Beheshti University of Medical Sciences Ilizarov frame in flap postoperative care Additive effect of Ilizarov frame application to routine wound care in reducing postoperative complications among patients with lower limb injury candidates for reverse flap surgery 2021-04-04 anticipated 20 Complete https://irct.ir/trial/62119 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of blocks is done by dividing the included patients into blocks with multiples of 2 (2, 4, 6, 8, etc.), then randomization of patients in each block is done in such a way that half of the patients are assigned to the experimental group and the other half to the control. Then we will choose the blocks randomly. This method ensures equal treatment allocation within each block when the complete block is used. 3 Other specified diseases of the skin (complications of free flaps). Intervention 1: Intervention group: 10 patients with severe lower limb injuries who are candidates for flap surgery will have an Ilizarov implanted after the flap surgery. Intervention 2: Control group: 10 patients with severe lower limb injuries who are candidates for flap surgery will be followed up after flap surgery without implanting an Ilizarov device and according to the routine surgical wound care protocol. Yes - There is a plan to make this available What will be shared: Participants' data file, study protocol, statistical analysis map, informed consent form and clinical study report will all be fully shareable after disclosing personal information. When: 6 months after printing the results To whom: The information will be available to anyone who requests access Conditions: Data are provided to study the study process or use in systematic review studies and meta-analysis. Where to obtain: Meisam Jafari Kafiabadi, Email:dr.jafari8567@yahoo.com, Address: School of Medicine ,Shahid Beheshti University of Medical Sciences, Yemen St., Shahid Chamran Highway, Tehran ,Iran Postal Code: 1985717443 How to obtain: After sending the request for access to information and specifying the type of requested information to the email of the person in charge of correspondence, they will prepare the requested information and send it to the applicant. Comments:
public Farsad Biglari
Tajrish square, Tehran
Tehran Iran (Islamic Republic of) 1989934148. +98 21 25719 pr_shohada@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Meisam Jafari Kafiabadi
Tajrish square
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 dr.jafari8567@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients above 18 years with extensive lower limb injury candidate for reverse flap surgery patients with lower limb injuries whose vessels are intact and the distal arterial-arterial connections are patent 18 years no limit Both Patients with vascular injuries of the lower extremities whose blood flow is impaired Patients with neural injuries EM0Y Other specified diseases of the skin Treatment - Surgery Treatment - Surgery Intervention group: 10 patients with severe lower limb injuries who are candidates for flap surgery will have an Ilizarov implanted after the flap surgery. Control group: 10 patients with severe lower limb injuries who are candidates for flap surgery will be followed up after flap surgery without implanting an Ilizarov device and according to the routine surgical wound care protocol. The rate of infection after surgery. Timepoint: At 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months and 6 months after surgery. Method of measurement: Examination of wounds for infection. Flap congestion after surgery. Timepoint: At 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months and 6 months after surgery. Method of measurement: Physical examination and observation of wound by surgeon. Bleeding rate after surgery. Timepoint: At 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months and 6 months after surgery. Method of measurement: Physical examination of the patient and assessing the volume of blood drawn from the patient's drain. Shahid Beheshti University of Medical Sciences Approved 2022-02-06 Ethics Committee of Shahid Beheshti University of Medical Sciences Iran, Tehran Velenjak St. , Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)