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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
176
Patients will receive immediate breast implant reconstruction using Bovine Pericardial Patch
Patients will receive immediate breast implant reconstruction using TiLOOP® Bra Mesh
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGComplication Rates
The rate of complications in the two groups
Time frame: up to 12 months after surgery
Patient satisfaction-Breast-Q questionnaire
We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.
Time frame: up to 12 months after surgery
Cosmetic outcome of reconstructed breast
Harris evaluation score was used to evaluate the aesthetic outcome of patients' reconstructed breasts, which was scored as "excellent," "good," "fair," "poor".
Time frame: Immediately, up to 3 months, 6 months and 12 months after surgery
The rate of surgical revision of reconstructed breasts
To record the rate of surgical revision events of the reconstructed breasts
Time frame: up to 12 months after surgery
Health economics-inpatient cost
Hospital inpatient costs due to immediate implant breast reconstruction
Time frame: up to 12 months after surgery, including the cost of surgical revision
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