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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008818
Enrollment
60
Registered
2023-09-22
Start date
2023-09-29
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Human tissue) : This study is a single-center, randomized, prospective, comparative study of patients who underwent mastectomy and prepectoral direct-to-implant breast reconstruction for breast

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? 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”)

Exclusion criteria

Exclusion criteria: ? 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

Design outcomes

Primary

MeasureTime frame
Subject satisfaction evaluation;Comparison of capsular contractures;Comparison of operation time according to ADM type

Secondary

MeasureTime frame
Complication rate assessment

Countries

Korea, Republic of

Contacts

Public ContactHan Hyun Ho

Asan Medical Center

tripleh1952@gmail.com+82-2-3010-3600

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026