TiLoop® Bra for Breast Reconstruction

Study Overview
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Brief Summary
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A new approach for single stage implant based breast reconstruction (BR) is the use of a titanium-coated polypropylene mesh (TCPM) as an alternative to acellular dermal matrix (ADM). These TCPM have a good biocompatibility and can be used in a similar way as ADM. This study addresses indications, limitations and complications of TCPM in implant based breast reconstruction.

Detailed Description
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An alternative to ADM is the usage of a titanium-coated polypropylene mesh (TCPM=TiLOOP(R) Bra), which is approved for breast reconstruction in Europe. The surgical approach is identical in comparison to ADM reconstruction and has been described previously. This titanium coated lightweight mesh consists of a monofilament structure and was initially invented for hernia repair which has a good biocompatibility. Observed cellular reactions like proliferation and apoptosis were at the lowest level when using this lightweight TCPM compared to not titanium-coated meshes (pure polypropylene (PP), pure lightweight PP mesh or PP mesh incorporating resorbable polyglactic acid). Histopathological analysis of an intraoperative sample of a TCPM after expander/implant BR demonstrated a well incorporated mesh with only weak inflammatory reactions. Preliminary data of in-vitro investigations at the investigators institute confirms the good biocompatibility of this TCPM in distinctive breast tissues (fibroblasts, fat cells, muscle cells) Although meshes are used in a large scale there are no sufficient clinical data regarding safety and outcome. In this multicenter study the investigators are able to investigate a large cohort of patients undergoing implant based breast reconstruction using a TCPM.

Official Title
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Multicenter Observational Study of Implant Based Breast Reconstruction Using a Titanium-coated Polypropylene Mesh

Conditions
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Patient and Surgical Related Risk Factors for Complications

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for immediate or secondary implant based breast reconstruction Exclusion Criteria: age < 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Reconstruction with TilOOP<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Who Received TiLOOP Mesh Reconstruction | Primary study endpoint was the identification of patient- and surgical factors predictive of adverse outcome and to develop recommendations for patients eligible for implant based breast reconstruction (IBBR) using TCPM. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication Rate | Secondary study outcome was the prevalence of complications. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast reconstruction, mesh, implant reconstruction, acellular dermal matrix, titanized polypropylene mesh, TiLOOP Bra, TiLOOP, implant based breast reconstruction