Breast defect
Conditions
Interventions
Single-arm group:PCL scaffold were implanted simultaneously during the resection of breast lesions, and autologous fat transplantation was performed late
Sponsors
Xi'an Jiaotong University Second Affiliated Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. There are no contraindications to surgery in routine preoperative examination; 2. Female patients aged 18-70 years, patients who are expected to have a missing volume of 20%-50% of the total breast volume after breast lesion resection, unilateral or bilateral; 3. Patients who voluntarily undergo surgical treatment, voluntarily join, are willing to sign the informed consent form, and are able to comply with the requirements of the study; 4. Patient has an acceptable MRI (i.e., no implantation of incompatible metal or metal devices, no history of severe claustrophobia); 5. The patient has enough donor area fat (abdomen, bilateral thighs, subcutaneous fat) for autologous fat grafting; 6. Agree to use their materials for academic research.
Exclusion criteria
Exclusion criteria: 1. Patients undergoing radical mastectomy or radical resection of the soft tissues of the chest wall; 2. Patients who have received breast or chest wall irradiation; 3. History of infection in the breast area 12 months before surgery; 4. Patients diagnosed with or with a history of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL); 5. Patient has any disease or disease, including uncontrolled diabetes mellitus (e.g., HbA1c >8%), clinically known to affect wound healing ability; 6. Patients with a known history of immunodeficiency, including HIV, concomitant systemic corticosteroid therapy, chemotherapy, concurrent hematologic malignancies, or other causes of secondary/primary immunodeficiency; 7. Known severe intercurrent or concurrent illnesses, including cardiovascular, respiratory, or immunological diseases, psychiatric disorders, alcohol or chemical dependence, possible allergies, which in the opinion of the investigator would compromise their safety or compliance or interfere with the interpretation of the study results; 8. Body mass index (BMI) lower than 20 and higher than 30 (patients with BMI over 30 can only be included if they pass the investigator's review; 9. Allergy to the PCL material (the inside of the patient's upper arm touches the implant material for 5 minutes to observe whether there is an allergic reaction); 10. Women who are currently pregnant or breastfeeding, or who plan to become pregnant within two years of breast surgery; 11. The patient is unable to undergo MRI examination; 12. Patient is unable or unwilling to comply with the treatment protocol; 13. Patients who are unwilling or unable to provide full informed consent, including but not limited to those with intellectual or psychiatric disabilities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| BREAST-Q questionnaire score;VAS chest aesthetic score; | — |
Countries
China
Contacts
Public ContactZhang Shun
Xi'an Jiaotong University Second Affiliated Hospital
Outcome results
None listed