Patients undergoing primary breast reconstruction with artificial prostheses Breast implants, breast tumor
Conditions
Interventions
In cases where a tissue expander (TE) or breast implant (BI) is inserted under the pectoralis major muscle and the defect of the serratus anterior or external oblique fascia is too large to cover the
PGA sheet (Neovert)
Sponsors
Mori Hiroki
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patients undergoing unilateral or bilateral mastectomy for benign or malignant breast tumors and hereditary breast and ovarian cancer syndrome who meet either of the following conditions Patients who are scheduled to undergo primary one-stage breast reconstruction using breast implants (BI) after resection. Patients scheduled for primary two-stage breast reconstruction using a tissue expander (TE) after res ection 3) Patients whose BI to be used is less than 650 ml 4) Patients with breast cancer, Stage IIIA or less in the preoperative diagnosis, without skin invasion, pectoralis major muscle invasion, or advanced lymph node metastasis (N2a or higher) 5) Patients who are at least 18 years of age at the time of obtaining consent 6) Patients who have given written consent to participate in this clinical study
Exclusion criteria
Exclusion criteria: 1) Patients allergic to PGA 2) Patients with active infection 3) Patients with a history of radiation to the chest area to be reconstructed (e.g., ipsilateral mammary gland or axilla, ipsilateral lung) 4) Patients who have smoked within 4 weeks prior to obtaining consent 5) Patients with poorly controlled diabetes mellitus 6) Patients who need to receive radiation to the reconstructed breast in the early postoperative period (within 1 month) 7) Patients with conditions that impair wound healing, such as inadequate local blood flow or the effects of medications 8) Pregnant or lactating patients 9)Other patients who are judged by the principal investigator (subinvestigator) to be inappropriate as subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Extraction rate of TE or BI within 3 months after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Infection rate within 3 months after surgery 2)Skin necrosis rate within 3 months after surgery 3)Extraction rate of TE or BI during all periods 4)Operating time 5)Duration of drain placement 6)Period of hospitalization 7)Percentage of successful primary reconstruction Safety endpoints Percentage of adverse events and failures | — |
Contacts
Public ContactMami Yasunaga
Institute of Science Tokyo Hospital
Outcome results
None listed