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IRCT20180309039013N1 IRCT 2018-06-08 Shiraz University of Medical Sciences Evaluation of the effect of TauroLock™ and piperacillin-tazobactam in secondary prophylaxis of Port-Catheter infection. Comparative clinical study of the effectiveness of TauroLock™ solution with piperacillin-tazobactam as secondary prophylaxis of Port-Catheter infection in children with cancer 2018-03-21 anticipated 50 Complete https://irct.ir/trial/30067 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, block randomization method was used which the patient was the randomization unit. For this purpose, computer software was used to define the blocks, Blinding description: In this study, the participants and the evaluator (the microbiologist who records the final result of the growth medium) will be unaware of the intervention groups. For blinding the statistical specialist, the encoding of the groups and participants will be done by a third person and the code definition will not be available to the statistician. additionally, due to the nature of the study, physician and the nurses will be aware of the control and intervention groups. 3 Infection due to port catheter. Intervention 1: Intervention group: Individuals in this group will be injected from the antibiotic solution of Piperacillin Tazobactam in proportion to the port volume, 3-5 cc. Intervention 2: Control group: Individuals in this group will be injected from the TauroLock™ solution in proportion to the port volume, 3-5 cc. 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 The journal that will publish our article may do not permit us to release data for some years. We need to speak with other co-workers for making any decision.
public Ali Amanati
Amir Oncology Hospital,Station 11of Farhangshahr, Shiraz
Shiraz Iran (Islamic Republic of) ۷۱۹۳۶۳۶۵۶۸ +98 71 3632 3731 Ali_amanati_1356@yahoo.com Shiraz University of Medical Sciences scientific Ali Amanati
Amir Oncology Hospital,Station 11 of Farhangshahr, Shiraz
Shiraz Iran (Islamic Republic of) ۷۱۹۳۶۳۶۵۶۸ +98 71 3632 3731 Ali_amanati_1356@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Having Port-Catheter Age between 0-19 Having cancer 1 day 19 years Both Critically ill patients Patients with severe coagulation problems No permission from child's parents T85.7 Infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts Prevention Prevention Intervention group: Individuals in this group will be injected from the antibiotic solution of Piperacillin Tazobactam in proportion to the port volume, 3-5 cc. Control group: Individuals in this group will be injected from the TauroLock™ solution in proportion to the port volume, 3-5 cc. The rate of infection of systemic bloodstream incidence due to port infection. Timepoint: Before the beginning of the intervention, once a day during the intervention, and at the end of the intervention. Method of measurement: Positive blood culture according to standard microbiological process. Port survival rate (No need to exit port or reload). Timepoint: Once a day during the intervention, and at the end of the intervention. Method of measurement: I will record the change of port by observation. Shiraz University of Medical Sciences Approved 2016-11-14 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences,setad Ave.,Zand Blvd.,Shiraz Shiraz Fars Iran (Islamic Republic of)