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IRCT20211207053318N1 IRCT 2021-12-19 Arak University of Medical Sciences outcome of intra-medullary nailing surgery in femoral shaft fractures with and without wound washing Comparison of the outcome of intra-medullary nailing surgery in femoral shaft fractures with and without wound washing 2022-01-02 anticipated 64 Complete https://irct.ir/trial/60652 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated into 2 groups using a permuted balanced block randomization method with the size of blocks 4 and 8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method, Blinding description: In this study, patients as well as the project data analyzer and the project assistant who is responsible for completing the questionnaires will be unaware of the division of patients into two groups. 3 Femoral shaft fractures. Intervention 1: Intervention group 1: In this group, all the conditions of fullness and observation are observed first, and after the surgery of the operation area (muscles and bones), normal saline solution is washed in three layers of fascia and skin of the minister without washing. Intervention 2: Control group : In this group, first all the conditions are observed, but unlike the previous group, after surgery and before closing the wound, the operation area will be completely cleansed with about one liter of normal saline solution. 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 There is no more information
public Dr Alireza Kamali
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 alikamaliir@yahoo.com Arak University of Medical Sciences scientific Dr Mohsen Parsi Khameneh
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 d.a.alimadadi@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Non-pathological femoral shaft fracture age 15 to 65 years lack of underlying disease such as diabetes and hypertension Both gender 15 years 65 years Both No follow-up Death S72.0 Fracture of neck of femur Treatment - Surgery Treatment - Surgery Intervention group 1: In this group, all the conditions of fullness and observation are observed first, and after the surgery of the operation area (muscles and bones), normal saline solution is washed in three layers of fascia and skin of the minister without washing. Control group : In this group, first all the conditions are observed, but unlike the previous group, after surgery and before closing the wound, the operation area will be completely cleansed with about one liter of normal saline solution. Improving fracture location. Timepoint: 6 weeks, 3, 4 and 6 months after surgery. Method of measurement: Radiology examination. Wound healing. Timepoint: 2, 4 and 11 days after surgery. Method of measurement: Physical examination. Arak University of Medical Sciences Approved 2021-11-14 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)