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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prepectoral breast reconstruction with Mesh | Active Comparator | Immediate prepectoral breast reconstruction with Mesh |
|
| prepectoral breast reconstruction without Mesh | Experimental | Immediate prepectoral breast reconstruction without Mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prepectoral breast reconstruction | Procedure | Patients receive immediate prepectoral breast reconstruction |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Yin | Contact | +86-22-23340123 | 1171 | yinjian@tjmuch.com |
| Chunyong Han | Contact | +86-22-23340123 | 1171 | hancy_007@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| Tiloop Mesh implantation | Procedure | Patients receive immediate prepectoral breast reconstruction with Tiloop Mesh |
|
| 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 |