Completed

NCT Number: NCT01544023

TiLoop® Bra for Breast Reconstruction

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.

Completed

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Key information

Conditions

Patient and Surgical Related Risk Factors for Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Indication for immediate or secondary implant based breast reconstruction

Exclusion criteria

age < 18 years

Treatment and study plan

Primary outcomes

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 outcomes

Complication Rate

Time frame: 2 years

Secondary study outcome was the prevalence of complications.

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Mar 5, 2012
Registry last updated: Feb 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.