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Research and development of a simple and non-invasive prosthesis fixation method using a magnetic attachment

Research and development of a simple and non-invasive prosthesis fixation method using a magnetic attachment - Research and development of a simple and non-invasive prosthesis fixation method using a magnetic attachment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043172
Enrollment
11
Registered
2021-02-01
Start date
2021-02-01
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

microtia, nipple areola defect, orbital defect

Interventions

Patients use a silicone prosthesis with a magnetic attachment for 6 months. The frequency of use for 6 months is left to the patient (frequency of use is also one of the evaluation items)

Sponsors

University of the Ryukyus
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Patients who undergo plastic surgery at the University of the Ryukyu Hospital in the period of September 2022 after the approval of this examination, hoping for improvement in body surface tissue defects.(Microtia, tissue defect after breast cancer surgery, facial tissue defect after head and neck cancer, etc.). (2)Of the above (1), patients who do not wish to undergo prompt reconstructive surgery or cannot undergo it due to age or comorbidities. (3)Patients aged 6 to 90 years old who are communicative. (4)Patients who can go to the outpatient clinic for 6 months after the start of the study.

Exclusion criteria

Exclusion criteria: (1)The person does not want to wear the prosthesis. (2)Judgment ability is immature or deteriorated, and there is a risk of accidental ingestion. (3)There is a wound on the part where the prosthesis will be attached. (4)Skin diseases with a high risk of dermatitis (pemphigus, congenital epidermolysis bullosa, etc.).

Design outcomes

Primary

MeasureTime frame
Patient satisfaction after 1, 3 and 6 months of trial. Evaluated by questionnaire.

Secondary

MeasureTime frame
Ease of wearing, maintenance stability, skin condition (presence or absence of dermatitis), prosthesis strength

Countries

Japan

Contacts

Public ContactShogo Kasai

University of the Ryukyus Hospital Department of Plastic Surgery

kasaisho@med.u-ryukyu.ac.jp098-895-3331

Outcome results

None listed

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