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

NCT02562170 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-09-29

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

TiLoop Bra

DEVICE

Protexa

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Daphne Gschwantler-Kaulich, Ass.Prof.Dr. · Medical University Vienna

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-04-30
Completion
2015-05-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02562170 on ClinicalTrials.gov