N/A
N=207
TiLoop® Bra for Breast Reconstruction
Patient and Surgical Related Risk Factors for Complications
Bottom Line
View on ClinicalTrials.gov: NCT01544023 ↗Enrolled (actual)
207
Serious AEs
—
Results posted
Feb 2017
Primary outcome: Primary: Participants Who Received TiLOOP Mesh Reconstruction — 207 Patients with TiLOOP mesh reconstruction
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Rostock
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Who Received TiLOOP Mesh Reconstruction |
207 | — |
| SECONDARY Complication Rate |
13.4; 15.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Indication for immediate or secondary implant based breast reconstruction
Exclusion Criteria
- age < 18 years
Data sourced from ClinicalTrials.gov (NCT01544023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.