Clinical trial NCT01544023: TiLoop® Bra for Breast Reconstruction
Official title: Multicenter Observational Study of Implant Based Breast Reconstruction Using a Titanium-coated Polypropylene Mesh
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient and Surgical Related Risk Factors for Complications
Keywords: breast reconstruction
mesh
implant reconstruction
acellular dermal matrix
titanized polypropylene mesh
TiLOOP Bra
TiLOOP
implant based breast reconstruction
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2012-03-05
Enrollment: 207
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible for immediate or secondary implant based breast reconstruction.

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.

Eligibility criteria: Inclusion Criteria:

* Indication for immediate or secondary implant based breast reconstruction

Exclusion Criteria:

* age \< 18 years

Primary outcomes:
measure: Participants Who Received TiLOOP Mesh Reconstruction
timeFrame: 1 month
Secondary outcomes:
measure: Complication Rate
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Rostock
name: Max Dieterich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rostock
name: Bernd Gerber, Prof.
role: STUDY_CHAIR
References:
citation: 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.