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Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study

Breast Cancer Clinical Trial

Official title:
Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study

Clinical Trial Summary

Randomized controlled trial to look at early complications, cosmetic outcome, patient satisfaction and thickness of the tissue overlying the implant at the lower pole in immediate implant based breast reconstruction after Skin or Nipple Sparing Mastectomy with either a mesh (TiLOOP Bra) or an ADM (Protexa). Multicenter austrian trial with four breast cancer centers, 50 patients randomized 1:1 in the TiLoop or Protexa group.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02562170
Study type Interventional
Source Medical University of Vienna
Contact
Status Completed
Phase Phase 4
Start date July 2013
Completion date May 2015
View Details
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