Bovine Pericardial Patch, Implant Breast Reconstruction, TiLOOP® Bra Mesh
Conditions
Brief summary
This study is the first randomized and controlled study assessing the efficacy and safety of bovine pericardial patch and TiLOOP® bra mesh in patients with immediate implant breast reconstruction
Interventions
PROCEDUREBovine Pericardial Patch in Immediate Implant Breast Reconstruction
Patients will receive immediate breast implant reconstruction using Bovine Pericardial Patch
PROCEDURETiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction
Patients will receive immediate breast implant reconstruction using TiLOOP® Bra Mesh
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with I\ II stage breast cancer and Intent to receive NSM or SSM and implant based breast reconstruction 2. Do not smoking in the last 4 weeks or more 3. Mental health patients 4. Signed consent to participate
Exclusion criteria
1. Locally advanced stage patients or patients with distal metastasis 2. Patients received thoracic wall radiotherapy or will receive radiotherapy 3. Smoking in the last 4 weeks 4. Anticipated implant volume more than 600cc 5. Patients of pregnancy or lactation 6. Patients received neoadjuvant therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication Rates | up to 12 months after surgery | The rate of complications in the two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic outcome of reconstructed breast | Immediately, up to 3 months, 6 months and 12 months after surgery | Harris evaluation score was used to evaluate the aesthetic outcome of patients' reconstructed breasts, which was scored as excellent, good, fair, poor. |
| Patient satisfaction-Breast-Q questionnaire | up to 12 months after surgery | We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q. |
| The rate of surgical revision of reconstructed breasts | up to 12 months after surgery | To record the rate of surgical revision events of the reconstructed breasts |
| Health economics-inpatient cost | up to 12 months after surgery, including the cost of surgical revision | Hospital inpatient costs due to immediate implant breast reconstruction |
Countries
China
Contacts
Primary ContactChunyong Han, MD.
Backup ContactJian Yin, MD.
Outcome results
None listed