A Comparison Between Biological (Veritas®) vs Non Biological Mesh (TIGR®) in Immediate Breast Reconstruction

October 13, 2022 updated by: Vastra Gotaland Region

The Gothenburg TIGR/Veritas® Study - A Comparison Between Biological (Veritas®) vs Non Biological Mesh (TIGR®) in Immediate Breast Reconstruction

This study compares the outcome using a biological mesh (Veritas®) compared to a non biological mesh (TIGR®) in immediate breast reconstruction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The scientific evidence using different types of mesh in breast reconstruction is low at present with very few randomized controlled studies.

This study aims to compare a biological mesh (Veritas®) compared to a non biological mesh (TIGR®) in patients with hereditary increased risk of developing breast cancer operated with bilateral immediate breast reconstruction regarding implant loss rate,infections,total complication rate,aesthetic outcome, HQOL (health related quality of Life) and economics.

The patients will be enrolled to the study and sign an informed consent. At the operating theater the patient is randomized either to be reconstructed with Veritas® in one breast and TIGR® in the other breast..

The patients will be followed up according to a specified schedule until one year postoperatively as above.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

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

  • Sweden
    • Västra Götaland
      • Goteborg, Västra Götaland, Sweden, 41345
        • Dept . of plastic surgery

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with a confirmed breast cancer gene mutation or a calculated increased risk > 20% of developing a breast cancer during her lifetime.

Exclusion Criteria:

  • All patients that don't fulfill criteria above
  • Previous breast surgery

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Veritas® mesh
Use of Veritas mesh in conjunction with immediate breast reconstruction on one side
Device: Veritas®
Biologic mesh
Experimental: TIGR® mesh
Use of TIGR® mesh in conjunction with immediate breast reconstruction on one side
Device: TIGR®
Non biologic mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total complication rate
Time Frame: 12 months
Total complication rate within one year from surgery
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total infection rate
Time Frame: 30 days
Total infection rate within 30 days from surgery
30 days
Total implant loss rate
Time Frame: 12 months
Total implant loss rate within one year from surgery
12 months
Aesthetic outcome
Time Frame: 12 months
Aesthetic outcome at one year followup will be assessed by analysis of 3-dimensional pre- and post-op pictures in combination with a panel evaluating different aesthetical units of the breast
12 months
HQOL
Time Frame: 12 months
Three validated questionaries will be used to assess HQOL: EQ-5D,HAD30 and BreastQ. The patient fills in these preoperatively and one year postop
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost evaluation
Time Frame: 12 months
Cost evaluation at one year followup will be evaluated in cooperation with hospital Economists,calculating the total post per patient with or without a mesh.
12 months

Collaborators and Investigators

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

Sponsor

Vastra Gotaland Region

Investigators

  • Principal Investigator: Lars Kölby, Dept of plastic surgery Sahlgrenska University Hospital Gothenburg Sweden

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

Helpful Links

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

November 1, 2016

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

November 30, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (Estimate)

December 7, 2016

Study Record Updates

Last Update Posted (Actual)

October 17, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 189-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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