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

September 26, 2015 updated by: Daphne Gschwantler-Kaulich, Medical University of Vienna
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Exclusion Criteria:

  • prior local radiotherapy
  • inflammatory breast cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TiLoop Bra
immediate breast reconstruction with an implant and TiLoop Bra
Device: TiLoop Bra
Active Comparator: Protexa
immediate breast reconstruction with an implant and Protexa
Device: Protexa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications
Time Frame: up to two weeks after surgery
hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss
up to two weeks after surgery
change of baseline patient quality of life after 3 and 6 months
Time Frame: up to two weeks after surgery (=baseline), 3 and 6 months after surgery
questionnaire
up to two weeks after surgery (=baseline), 3 and 6 months after surgery
change of baseline cosmetic outcome after 3 and 6 months
Time Frame: up to two weeks after surgery (=baseline), 3 and 6 months after surgery
four point Harris Scale (1=poor, 4=excellent)
up to two weeks after surgery (=baseline), 3 and 6 months after surgery
change of baseline thickness of the tissue overlying the implant at the lower pole after 3 and 6 months
Time Frame: up to two weeks after surgery (=baseline), 3 and 6 months after surgery
The thickness of the tissue covering the implant in the lower pole im mm measured by ultrasound
up to two weeks after surgery (=baseline), 3 and 6 months after surgery
complications
Time Frame: 3 months after surgery
hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss
3 months after surgery
complications
Time Frame: 6 months after surgery
hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss
6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Daphne Gschwantler-Kaulich, Ass.Prof.Dr., Medical University Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

September 18, 2015

First Submitted That Met QC Criteria

September 26, 2015

First Posted (Estimate)

September 29, 2015

Study Record Updates

Last Update Posted (Estimate)

September 29, 2015

Last Update Submitted That Met QC Criteria

September 26, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1401/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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