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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000015844 |
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Date of registration:
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05/12/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Prospective intervention study to evaluate safety and effectiveness of newly developed silicon made drain fixing device.
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Scientific title:
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Prospective intervention study to evaluate safety and effectiveness of newly developed silicon made drain fixing device. - Prospective intervention study to evaluate safety and effectiveness of newly developed silicon made drain fixing device. |
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Date of first enrolment:
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2014/12/05 |
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Target sample size:
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10 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018441 |
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Study type:
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Interventional,observational |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Norihito
Wada |
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Address:
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35 Shinanomachi, Shinjyuku-ku, Tokyo 160-8582, Japan
160-8582
Japan |
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Telephone:
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03-3353-1211 |
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Email:
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nori-kkr@umin.ac.jp |
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Affiliation:
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Keio University, School of Medicine Department of Surgery |
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Name:
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Norihito
Wada |
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Address:
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35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
Japan |
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Telephone:
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03-3353-1211 |
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Email:
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nori-kkr@umin.ac.jp |
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Affiliation:
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Keio University, School of Medicine Department of Surgery |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Patients with infection or dermatitis on the drain insertion site. 2) Patients with mental disease who may have risk of self removal of the drain. 3) Patients with diabetes mellitus under insulin therapy, or under dialysis, or patients with immune deficiency. 4) Patients with severe obesity or emaciation. 5) Patients who doctor thinks inappropriate to participate in the study.
Age minimum:
20years-old
Age maximum:
90years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Patients who will have surgery in general surgery department.
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Intervention(s)
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To evaluate safety and effectiveness of silicon made newly developed drain fixing device for the patients having surgery in general surgery department.
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Primary Outcome(s)
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Safety (complication due to the use of newly developed drain fixing device, troubles with drain such as occlusion) Effectiveness (the pain caused by fixing the drain)
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Source(s) of Monetary Support
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None
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Ethics review
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Status: YES
Approval date: 27/09/2013
Contact:
med-rinri-jimu@adst.keio.ac.jp
Keio University School of Medicine, Ethics Committee
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/09/2015 |
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URL:
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