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NCT Number: NCT02985073

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dept . of plastic surgery

Gothenburg, Västra Götaland County, 41345, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Veritas®

Device

Biologic mesh

TIGR®

Device

Non biologic mesh

Primary outcomes

  1. Total complication rate

    Time frame: 12 months

    Total complication rate within one year from surgery

Secondary outcomes

  1. Total infection rate

    Time frame: 30 days

    Total infection rate within 30 days from surgery

  2. Total implant loss rate

    Time frame: 12 months

    Total implant loss rate within one year from surgery

  3. 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

  4. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Dec 7, 2016
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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