breast cancer
Conditions
Interventions
the experiment group:A biological mesh for breast tissue
the control group:TI-LOOP Product
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Patients aged 18 to 60 years old; (2) Patients with unilateral breast cancer at the TNM stage of 0, I and/or II; (3) Immediately breast reconstruction after mastectomy (SSM or NSM); (4) Patients BMI between 18.5 and 18.5 kg/m2; (5) Non-smoker and patients who have not been smoking for at least a month prior to the mastectomy; (6) Patients who have completed and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Inflammatory breast cancer patients; 2. Patients whose chest wall or breast have received radiotherapy or patients who are expected to undergo radiotherapy after surgery; 3. The expected breast prosthesis volume over 600mL; 4. Patients who reject porcine medical products due to religious beliefs and ethnic reasons; 5. Pregnant and lactating patients or patients with a plan to get pregnant in any period of the study; 6. Patients who had history of allergic reactions to any material of procine origin; 7. Contraindications to the use of the test product or the control product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of breast reconstruction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of Breast-Q score; | — |
Countries
China
Contacts
Public ContactWang Jing
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed