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An observational study to evaluate the safety and efficacy of MegaDerm Soft in patients who underwent breast reconstruction using the MegaDerm soft.

An observational study to evaluate the safety and efficacy of MegaDerm®Soft in patients who underwent breast reconstruction using the MegaDerm soft.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0007432
Enrollment
60
Registered
2022-06-22
Start date
2022-05-24
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

None listed

Interventions

None listed

Sponsors

Soon Chun Hyang University Hospital Bucheon
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All subjects can participate in the clinical trial only when all of the following criteria are met. ? the patients who signed informed consent form ? Those aged 20 or over and under 65 years of age ? the patients who underwent breast reconstruction using Megaderm soft

Exclusion criteria

Exclusion criteria: if any of the following items apply, the subject is excluded from the clinical trial. ? overweight (BMI =40 kg/m2) ? Pregnant ? Other patients who were judged to be difficult to participate in this study by the investigator

Design outcomes

Primary

MeasureTime frame
aesthetic outcome evaluation—

Secondary

MeasureTime frame
complication evaluation;capsular contracture evaluation;satisfaction evaluation—

Countries

Korea, Republic of

Contacts

Public ContactEunsoo Park

Soon Chun Hyang University Hospital Bucheon

peunsoo@naver.com+82-32-621-5319

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026