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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bovine Pericardial Patch | Active Comparator | Immediate implant breast reconstruction using bovine pericardial patch. n=88 |
|
| TiLOOP® Bra Mesh | Experimental | Immediate implant breast reconstruction using TiLOOP® Bra Mesh. n=88 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bovine Pericardial Patch in Immediate Implant Breast Reconstruction | Procedure | Patients will receive immediate breast implant reconstruction using Bovine Pericardial Patch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rates | The rate of complications in the two groups | up to 12 months after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunyong Han, MD. | Contact | +86-22-23340123 | 1174 | hancy_007@126.com |
| Jian Yin, MD. | Contact | +86-22-23340123 | 1171 | yinjian@tjmuch.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Yin, MD. | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| 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® Bra Mesh in Immediate Implant Breast Reconstruction | Procedure | Patients will receive immediate breast implant reconstruction using TiLOOP® Bra Mesh |
|
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 |