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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. - Prospective intervention study to evaluate safety and effectiveness of newly developed silicon made drain fixing device.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015844
Enrollment
10
Registered
2014-12-05
Start date
2014-12-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who will have surgery in general surgery department.

Interventions

To evaluate safety and effectiveness of silicon made newly developed drain fixing device for the patients having surgery in general surgery department.

Sponsors

Keio University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who are scheduled to have surgery in general surgery department. 2) Patients who will use 19Fr silicon drain for surgery. 3) Patients with over 20 years old, and below 90 years old. 4) PS 0 or 1. 5) Provided with written informed conscent.

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactNorihito Wada

Keio University, School of Medicine Department of Surgery

nori-kkr@umin.ac.jp03-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026