TiLoop® Bra for Breast Reconstruction

Completed

• Conditions: Patient and Surgical Related Risk Factors for Complications

• Registration Number: NCT01544023
• Lead Sponsor: University of Rostock

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.

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 Timeline

• Study Start: 2010-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2012-02-28
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-05
• Results First Submitted: 2015-11-30
• Status Verified: 2016-12
• Results First Submitted QC: 2016-12-26
• Last Update Submitted: 2016-12-26
• Results First Posted: 2017-02-16
• Last Update Posted: 2017-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 207

Inclusion Criteria

• Indication for immediate or secondary implant based breast reconstruction

Exclusion Criteria

• age < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participants Who Received TiLOOP Mesh Reconstruction	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

Name	Time	Method
Complication Rate	2 years	Secondary study outcome was the prevalence of complications.