A Comparison Between Biological (Veritas®) vs Non Biological Mesh (TIGR®) in Immediate Breast Reconstruction
NCT ID: NCT02985073
Last Updated: 2022-10-17
Study Results
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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COMPLETED
NA
24 participants
INTERVENTIONAL
2016-11-30
2022-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Veritas® mesh
Use of Veritas mesh in conjunction with immediate breast reconstruction on one side
Veritas®
Biologic mesh
TIGR® mesh
Use of TIGR® mesh in conjunction with immediate breast reconstruction on one side
TIGR®
Non biologic mesh
Interventions
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Veritas®
Biologic mesh
TIGR®
Non biologic mesh
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous breast surgery
20 Years
FEMALE
No
Sponsors
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Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Principal Investigators
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Lars Kölby
Role: PRINCIPAL_INVESTIGATOR
Dept of plastic surgery Sahlgrenska University Hospital Gothenburg Sweden
Locations
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Dept . of plastic surgery
Gothenburg, Västra Götaland County, Sweden
Countries
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References
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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. doi: 10.1080/2000656X.2019.1704766. Epub 2019 Dec 20.
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. Epub 2020 Jun 9.
Hansson E, Edvinsson AC, Elander A, Kolby 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: 10.1002/jso.26227. Epub 2020 Oct 13.
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 Reconstr Aesthet Surg. 2022 Nov;75(11):4133-4143. doi: 10.1016/j.bjps.2022.08.013. Epub 2022 Aug 23.
Related Links
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Full text article
Full text article
Other Identifiers
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189-16
Identifier Type: -
Identifier Source: org_study_id
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