Single center, randomized, prospective, comparative study to evaluate the efficacy and safety of Megaderm® Star” in breast reconstruction with implants after mastectomy in breast cancer patients
- Conditions
- Neoplasms
- Registration Number
- KCT0008818
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 60
? Patients who signed the subject description and consent form
? Patients between the ages of 20 and 79
? For breast cancer treatment, patients who are scheduled to perform radial incision during mastectomy
? Patients who are scheduled to undergo Prepectoral direct-to-implant breast reconstruction by applying ADM (MegaDerm® STAR” or MegaDerm® Flex HD”)
? Patients who have previously undergone mastectomy, breast augmentation, or breast reconstruction
? In case both breasts are performed at the same time or in case of reduction of the opposite side
? In case of inserting an expander
? Patients who have undergone organ transplantation and are taking immunosuppressants
? Patients whose mental state may affect the progress of the clinical trial due to alcohol or drug abuse
? Patients who are unable to proceed with the survey conducted in this clinical trial
? Patients who find it difficult to conduct this clinical trial at the discretion of the researcher
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subject satisfaction evaluation;Comparison of capsular contractures;Comparison of operation time according to ADM type
- Secondary Outcome Measures
Name Time Method Complication rate assessment