Bovine Pericardial Patch and TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction.

Study Overview
=================
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

Official Title
-----------------
A Randomized and Controlled Study of Efficacy and Safety of Bovine Pericardial Patch and TiLOOP® Bra Mesh in Patients With Immediate Implant Breast Reconstruction.

Conditions
-----------------
Implant Breast Reconstruction, TiLOOP® Bra Mesh, Bovine Pericardial Patch

Intervention / Treatment
-----------------
* Procedure: Bovine Pericardial Patch in Immediate Implant Breast Reconstruction
* Procedure: TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with I II stage breast cancer and Intent to receive NSM or SSM and implant based breast reconstruction Do not smoking in the last 4 weeks or more Mental health patients Signed consent to participate Exclusion Criteria: Locally advanced stage patients or patients with distal metastasis Patients received thoracic wall radiotherapy or will receive radiotherapy Smoking in the last 4 weeks Anticipated implant volume more than 600cc Patients of pregnancy or lactation Patients received neoadjuvant therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bovine Pericardial Patch<br>Immediate implant breast reconstruction using bovine pericardial patch. n=88 | Procedure: Bovine Pericardial Patch in Immediate Implant Breast Reconstruction<br>* Patients will receive immediate breast implant reconstruction using Bovine Pericardial Patch<br>|
| Experimental: TiLOOP® Bra Mesh<br>Immediate implant breast reconstruction using TiLOOP® Bra Mesh. n=88 | Procedure: TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction<br>* Patients will receive immediate breast implant reconstruction using TiLOOP® Bra Mesh<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication Rates | The rate of complications in the two groups | up to 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction-Breast-Q questionnaire | We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q. | 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. | 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 | up to 12 months after surgery | 
| Health economics-inpatient cost | Hospital inpatient costs due to immediate implant breast reconstruction | up to 12 months after surgery, including the cost of surgical revision |