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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Hereditary Breast and Ovarian Cancer Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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TiLoop Bra

immediate breast reconstruction with an implant and TiLoop Bra

Group Type ACTIVE_COMPARATOR

TiLoop Bra

Intervention Type DEVICE

Protexa

immediate breast reconstruction with an implant and Protexa

Group Type ACTIVE_COMPARATOR

Protexa

Intervention Type DEVICE

Interventions

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TiLoop Bra

Intervention Type DEVICE

Protexa

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* breast cancer patients with indication for skin or nipple sparing mastectomy
* BRCA1/2 mutation carriers with indication for skin or nipple sparing mastectomy