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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02985073
• Other study ID #: 189-16
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: September 2022

Study information

• Verified date: October 2022
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2022
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Veritas®
Biologic mesh
• TIGR®
Non biologic mesh

Locations

Country	Name	City	State
Sweden	Dept . of plastic surgery	Goteborg	Västra Götaland

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Hansson E, Burian P, Hallberg H. Comparison of inflammatory response and synovial metaplasia in immediate breast reconstruction with a synthetic and a biological mesh: a randomized controlled clinical trial. J Plast Surg Hand Surg. 2020 Jun;54(3):131-136. — View Citation

Hansson E, Edvinsson AC, Elander A, Kölby L, Hallberg H. First-year complications after immediate breast reconstruction with a biological and a synthetic mesh in the same patient: A randomized controlled study. J Surg Oncol. 2021 Jan;123(1):80-88. doi: 10 — View Citation

Hansson E, Edvinsson AC, Hallberg H. Drain secretion and seroma formation after immediate breast reconstruction with a biological and a synthetic mesh, respectively: A randomized controlled study. Breast J. 2020 Sep;26(9):1756-1759. doi: 10.1111/tbj.13921 — View Citation

Paganini A, Meyer S, Hallberg H, Hansson E. Are patients most satisfied with a synthetic or a biological mesh in dual-plane immediate breast reconstruction after 5 years? A randomized controlled trial comparing the two meshes in the same patient. J Plast — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost evaluation	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
Primary	Total complication rate	Total complication rate within one year from surgery	12 months
Secondary	Total infection rate	Total infection rate within 30 days from surgery	30 days
Secondary	Total implant loss rate	Total implant loss rate within one year from surgery	12 months
Secondary	Aesthetic outcome	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
Secondary	HQOL	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

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