None listed
Conditions
Interventions
Procedure/Surgery : Breast reconstruction surgery will be performed in accordance with the standard surgical method of the operation, and if nerve transplantation using allogeneic nerves is possible d
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women between the ages of 20 and 79. 2. Patients undergoing breast reconstruction using implants following a mastectomy, who understand the purpose of the study and have provided informed consent to participate.
Exclusion criteria
Exclusion criteria: 1. Patients currently taking immunosuppressants or systemic steroids, including oral and injectable formulations (only applicable to those on continuous treatment for at least 4 weeks). 2. Individuals whose mental status, such as alcohol or drug abuse, may interfere with the progress of the clinical study. 3. Individuals who are unable to complete the surveys/questionnaires conducted in this clinical study. 4. Individuals who have participated in another clinical study within 120 days prior to screening (participation is allowed if the investigator determines that the previous study does not affect the current study). 5. Individuals with a history of prior surgery at the breast reconstruction site, such as breast augmentation, tumor excision, or breast-conserving surgery (BCS). 6. Women who are pregnant, breastfeeding, or of childbearing potential during the clinical trial who do not agree to use medically accepted methods of contraception (e.g., sterilization, intrauterine devices (IUDs), oral contraceptives in combination with barrier methods, other hormonal delivery systems with barrier methods, or use of a diaphragm/condom with contraceptive creams, jellies, or foam). 7. Other cases where the investigator deems the subject unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the breast sensory recovery in accordance with the Semmes-Weinstein monofilament test | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject's self-assessment of satisfaction after breast reconstruction by the Breast-Q reconstruction module(survey) | — |
Countries
Korea, Republic of
Contacts
Public ContactJAEHOON JEONG
Seoul National University Bundang Hospital
Outcome results
None listed