An observational study to evaluate the safety and efficacy of MegaDerm Soft in patients who underwent breast reconstruction using the MegaDerm soft.
Not Applicable
Recruiting
- Conditions
- Neoplasms
- Registration Number
- KCT0007432
- Lead Sponsor
- Soon Chun Hyang University Hospital Bucheon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method aesthetic outcome evaluation
- Secondary Outcome Measures
Name Time Method complication evaluation;capsular contracture evaluation;satisfaction evaluation