Single center, randomized, prospective, comparative study to evaluate the effect of ADM coverage method in prepectoral implant breast reconstructio
- Conditions
- Neoplasms
- Registration Number
- KCT0007046
- Lead Sponsor
- Korea University Anam Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 30
1) Patients over the age of 19
2) Patients who need mastectomy for breast cancer
3) Patients who are planning to undergo one stage immediate breast reconstruction (prepectoral) using an implant after mastectomy (skin preservation/nipple preservation)
4) Patients who will use acellular allogeneic dermis for breast reconstruction
5) Patients who consent to the clinical study and can follow-up during the study period
1) Patients undergoing chemotherapy for cancer other than breast cancer
2) Patients with confirmed local recurrence or systemic metastasis of breast cancer
3) Patients who are scheduled to undergo delayed breast reconstruction (two stage) during breast reconstruction
4) Patients with underlying diseases such as infectious diseases, autoimmune diseases (especially rheumatic diseases, etc.), and blood clotting disorders
5) Patients with systemic diseases other than breast cancer (especially uncontrolled diabetes, etc.)
6) Pregnant or lactating women
7) Patients who are judged by the principle investigator to be difficult to participate in the study
(Current smokers, moderate obesity, etc.)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of Capsular Contracture after Reconstructive Surgery
- Secondary Outcome Measures
Name Time Method Patient Satisfaction Assessment After Reconstructive Surgery;Comparison of Capsular Contracture after Reconstructive Surgery