Pre-pectoral Breast Reconstruction With or Without Mesh

Study Overview
=================
Brief Summary
-----------------
To explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that when TiLOOP Mesh is not used.

Detailed Description
-----------------
The clinical study aims to explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that not using TiLOOP Mesh.

Official Title
-----------------
A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Mesh

Conditions
-----------------
Prepectoral Breast Reconstruction, TiLOOP Mesh

Intervention / Treatment
-----------------
* Procedure: prepectoral breast reconstruction
* Procedure: Tiloop Mesh implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult women aged 18-65 years who plan to undergo unilateral or bilateral immediate prepectoral prothesis breast reconstruction; SSM or NSM or Skin-Reducing Mastectomy for breast cancer patients or prophylactic mastectomy; Tissue expander size =<800cc, implant size =<600cc; The blood perfusion of breast skin flap was well; Do not smoking in the last 4 weeks or more Patients with normal expectations and mental health for breast reconstruction; Signed consent to participate Exclusion Criteria: Poor perfusion of breast mastectomy flap; II stage breast reconstruction patients; History of chest radiotherapy; BMI greater than 35; Patients who have not quit smoking within the last 4 weeks;

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: prepectoral breast reconstruction with Mesh<br>Immediate prepectoral breast reconstruction with Mesh | Procedure: prepectoral breast reconstruction<br>* Patients receive immediate prepectoral breast reconstruction<br>Procedure: Tiloop Mesh implantation<br>* Patients receive immediate prepectoral breast reconstruction with Tiloop Mesh<br>|
| Experimental: prepectoral breast reconstruction without Mesh<br>Immediate prepectoral breast reconstruction without Mesh | Procedure: prepectoral breast reconstruction<br>* Patients receive immediate prepectoral breast reconstruction<br>|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor Complication Rates | The rate of minor complications in the two groups | up to 12 months after surgery | 
| Rates of capsule contracture | The rates of capsule contracture in the two groups | up to 24 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 | 
| The rate of implant or tissue expander removal | The rate of implant or tissue expander removal in the two groups | up to 12 months after surgery |