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TiLoop® Bra for Breast Reconstruction

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ClinicalTrials.gov Identifier: NCT01544023
Recruitment Status : Completed
First Posted : March 5, 2012
Results First Posted : February 16, 2017
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Max Dieterich, University of Rostock

Study Description
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Brief Summary:
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.

Condition or disease
Patient and Surgical Related Risk Factors for Complications

Detailed Description:
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.
Study Design
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Study Type : Observational
Actual Enrollment : 207 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicenter Observational Study of Implant Based Breast Reconstruction Using a Titanium-coated Polypropylene Mesh
Study Start Date : January 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Breast Reconstruction with TilOOP


Outcome Measures
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Primary Outcome Measures :
  1. Participants Who Received TiLOOP Mesh Reconstruction [ Time Frame: 1 month ]
    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.


Secondary Outcome Measures :
  1. Complication Rate [ Time Frame: 2 years ]
    Secondary study outcome was the prevalence of complications.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients eligible for immediate or secondary implant based breast reconstruction.
Criteria

Inclusion Criteria:

  • Indication for immediate or secondary implant based breast reconstruction

Exclusion Criteria:

  • age < 18 years
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544023


Sponsors and Collaborators
University of Rostock
Investigators
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Principal Investigator: Max Dieterich, MD University of Rostock
Study Chair: Bernd Gerber, Prof. University of Rostock
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Max Dieterich, Principle investigator, University of Rostock
ClinicalTrials.gov Identifier: NCT01544023    
Other Study ID Numbers: TL001
First Posted: March 5, 2012    Key Record Dates
Results First Posted: February 16, 2017
Last Update Posted: February 16, 2017
Last Verified: December 2016
Keywords provided by Max Dieterich, University of Rostock:
breast reconstruction
mesh
implant reconstruction
acellular dermal matrix
 titanized polypropylene mesh
TiLOOP Bra
TiLOOP
implant based breast reconstruction