None listed
Conditions
Interventions
Others(biological product) : Before use of the investigational human tissue product (CGRealloputty), the expiration date indicated on the product label and any signs of package damage shall be checked
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female subjects aged = 19 years 2. Patients who underwent implant-based breast reconstruction and developed rippling deformity at least 6 months postoperatively, and who wish to receive corrective treatment 3. Subjects who voluntarily sign written informed consent after being fully informed of the purpose and procedures of the study 4. Subjects who are considered able and willing to participate until the end of the clinical trial
Exclusion criteria
Exclusion criteria: 1. Patients who did not develop rippling or developed rippling less than 6 months after breast reconstruction 2. Patients whose rippling is suspected to be caused by skin tissue damage rather than subcutaneous volume deficiency (e.g., radiation-induced damage, vascular/structural defect, impaired wound healing) 3. Patients who are undergoing another clinical study at the same injection site that could interfere with the evaluation of safety or efficacy 4. Pregnant, breastfeeding, or planning to become pregnant during the study period 5. Patients deemed unsuitable for participation in this clinical trial at the investigator’s discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence and severity of rippling at the injection site | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Breast-Q questionnaire score;Change in rippling severity; Change in breast skin thickness measured by ultrasound;Assessment of rippling presence at 12 months post-treatment | — |
Countries
Korea, Republic of
Contacts
Public ContactGa Hye Lee
Yonsei University Health System, Severance Hospital
Outcome results
None listed