evaluation safety and efficacy of nerve allograft MegaNerve Prime® in breast reconstruction

Authors
Category Primary study
Registry of TrialsKorean Clinical Trials Database
Year 2023
INTERVENTION: Medical Device : Patients who meet the selection criteria will be assigned according to the randomization table. On the day of surgery, the test group is transplanted MegaNerve Prime® to the target patient, and the control group is not proceed with neurotransplantation. Validity and safety are evaluated by visiting for 2 weeks, 3 months, 6 months, and 12 months after surgery. CONDITION: Neoplasms PRIMARY OUTCOME: Semmes Weinstein Monofilaments(SWMF) SECONDARY OUTCOME: BREAST‐Q Assessment Semmes Weinstein Monofilaments(SWMF) Sensory satisfaction assessment INCLUSION CRITERIA: 1) Patients over 19 to under 80 years of age 2) Patients scheduled to undergo direct to implant (DTI) for breast cancer 3) Patients who agree to a clinical study and can follow up during the trial period 4) Patients with peripheral nerve damage or nerve defect due to disease and trauma
Epistemonikos ID: 1a8bfa2cf693c878a2834fce1b820641bc0ab7d8
First added on: Feb 20, 2024