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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Reconstruction with TilOOP |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rate | Secondary study outcome was the prevalence of complications. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients eligible for immediate or secondary implant based breast reconstruction.
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| Name | Affiliation | Role |
|---|---|---|
| Max Dieterich, MD | University of Rostock | Principal Investigator |
| Bernd Gerber, Prof. | University of Rostock | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23806958 | Derived | Dieterich M, Paepke S, Zwiefel K, Dieterich H, Blohmer J, Faridi A, Klein E, Gerber B, Nestle-Kraemling C. Implant-based breast reconstruction using a titanium-coated polypropylene mesh (TiLOOP Bra): a multicenter study of 231 cases. Plast Reconstr Surg. 2013 Jul;132(1):8e-19e. doi: 10.1097/PRS.0b013e318290f8a0. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TiLOOP | Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP" Bra (pfm medical, Cologne, Germany) were included. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | TiLOOP | Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP" Bra (pfm medical, Cologne, Germany) were included. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Patients with TiLOOP mesh reconstruction | 1 month |
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Retrospective chart analysis. With Follow up up to 2 years
Adverse Events were not collected/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TiLOOP | Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP" Bra (pfm medical, Cologne, Germany) were included. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Max Dieterich | University of Rostock, Klinikum Südstadt der Hansestadt Rostock, Frauenklinik | +4938144016145 | max.dieterich@uni-rostock.de |
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| years |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Complication Rate | Secondary study outcome was the prevalence of complications. | Posted | Number | percentage of participants | 2 years |
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