None listed
Conditions
Interventions
Others(Human tissue) : Intervention group
The intervention group will receive MegaDerm® (Acellular Dermal Matrix, ADM) in a circular design tailored to fit tissue expanders with a volume of 250–350 cc
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: ? Patients aged between 19 and 70 years ? Patients scheduled to undergo prepectoral implant immediate two-stage breast reconstruction following total mastectomy for breast cancer treatment ? Patients who provide informed consent to participate in the clinical trial and are able to comply with follow-up visits during the study period
Exclusion criteria
Exclusion criteria: ? Patients receiving chemotherapy for cancers other than breast cancer ? Patients with confirmed local recurrence or distant metastasis of breast cancer ? Patients with underlying conditions such as infectious diseases, systemic autoimmune diseases (particularly rheumatoid disorders), or coagulation disorders ? Patients with systemic diseases other than breast cancer ? Pregnant or breastfeeding women ? Patients deemed unsuitable for participation in the clinical trial at the discretion of the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of ADM(Acelluar Dermal Matrix) application time during surgery (minutes);Safety Assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of total operative time;Assessment of tissue expander expansion period ;Assessment of patient satisfaction using the Breast-Q;Assessment of investigator satisfaction;Assessment of Capsule Contracture;Assessment of complication incidence rate | — |
Countries
Korea, Republic of
Contacts
Public ContactKyong Je Woo
Samsung Medical Center
Outcome results
None listed