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TiLoop® Bra for Breast Reconstruction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Max Dieterich, University of Rostock
ClinicalTrials.gov Identifier:
NCT01544023
First received: February 28, 2012
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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
Patient and Surgical Related Risk Factors for Complications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Observational Study of Implant Based Breast Reconstruction Using a Titanium-coated Polypropylene Mesh

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rostock:

Primary Outcome Measures:
  • Risk factor for complications [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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:
  • Complication rate [ Time Frame: Until data evaluation ] [ Designated as safety issue: No ]
    Secondary study outcome was the prevalence of complications and implant failure.


Enrollment: 242
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

An alternative to ADM is the usage of a titanium-coated polypropylene mesh (TCPM), 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544023

Sponsors and Collaborators
University of Rostock
Investigators
Principal Investigator: Max Dieterich, MD University of Rostock
Study Chair: Bernd Gerber, Prof. University of Rostock
  More Information

No publications provided

Responsible Party: Max Dieterich, Principle investigator, University of Rostock
ClinicalTrials.gov Identifier: NCT01544023     History of Changes
Other Study ID Numbers: TL001
Study First Received: February 28, 2012
Last Updated: January 15, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Rostock:
breast reconstruction
mesh
implant reconstruction
acellular dermal matrix
 titanized polypropylene mesh
TiLOOP Bra
TiLOOP
implant based breast reconstruction

ClinicalTrials.gov processed this record on May 19, 2013