None listed
Conditions
Interventions
Medical Device : As a method of filling the defective area after breast conserving surgery, the study group uses a combination of diced type MegaDerm® and MegaFill® (micronized ADM filler), and the co
Sponsors
Kosin University Gospel Hospital
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. ? Those between the ages of 20 to under 65 years ? Subject who will be get a breast partial resection for breast cancer ? Subject who will be get a oncoplastic breast-conserving surgery using diced MegaDerm® or a combination of diced MegaDerm® and MegaFill® (micronized ADM filler)
Exclusion criteria
Exclusion criteria: If any of the following items apply, the subject is excluded from the clinical trial. Subject who have undergone radiation therapy before surgery Subject who will be get a radiation therapy after surgery Subject who will be get an additional breast surgery due to local recurrence after breast conserving surgery Subject who have an uncontrolled seriously infection Subject who have autoimmune diseases Subject with blood clotting disorders Subject who are judged by medical investigator to be considered unsuitable for this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of cosmetic outcomes by independent evaluators (Aesthetic Items Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of subject cosmetic satisfaction (10-point scale);Quantitative evaluation of volume changes in ADM used;Evaluation of complications | — |
Countries
Korea, Republic of
Contacts
Public ContactGiryeong Baek
Kosin University Gospel Hospital
Outcome results
None listed