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IRCT20190528043740N1 IRCT 2019-06-07 Darman Afarin Noandish Afagh Cranfixer Clinical Trial of Cranfixer 2018-02-15 anticipated 50 Complete https://irct.ir/trial/39837 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Flap Fixation instrument (Burr Hole Cover). Intervention group: Cranfixer. Yes - There is a plan to make this available What will be shared: Table of postoperative Information of patients. Data will be shared after unidentifiable people. When: Access to data is possible at the time of publishing results To whom: Individuals approved by the this team and the manufacturer Conditions: If a person wants to access patient files, such as CT-scan for further study, it is possible with the manufacturer's permission. furthermore, the provided report from this study should be published with permission and the name of the manufacturer. Where to obtain: Darman Afarin Noandish Afagh Company How to obtain: After the Submission of request and the confirmation, the information is provided by the company representative. Comments:
public Seyed Roholah Ghodsi
Qods st.
Tehran Iran (Islamic Republic of) 1417614361 +98 21 8338 4167 roholahghodsi@gmail.com Darman Afarin Noandish Afagh scientific Seyed Mohammad Ghodsi
Keshavarz Blv.
Tehran Iran (Islamic Republic of) 1417653761 +98 21 8338 4167 ghodsism@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Neurosurgery that leads to the separation of the skull's flap no limit no limit Both T84.2 Mechanical complication of internal fixation device of other bones Treatment - Surgery Intervention group: Cranfixer Skull Flap Loosining. Timepoint: At least 6 month after surgery. Method of measurement: Qualitative Study (Touch). Infection. Timepoint: 2 to 4 weeks after surgery. Method of measurement: Infection detection. Non-Touchable from The skin. Timepoint: At least 6 month after surgery. Method of measurement: Qualitative Study (Touch). Darman Afarin Noandish Afagh Approved 2018-12-11 Vice-Chancellor in Research Affairs - Tehran University of Medical Sciences Qods st., Tehran University of Medical Science (TUMS) Tehran Tehran Iran (Islamic Republic of)