Clinical trial NCT02985073: A Comparison Between Biological (Veritas®) vs Non Biological Mesh (TIGR®) in Immediate Breast Reconstruction
Official title: The Gothenburg TIGR/Veritas® Study - A Comparison Between Biological (Veritas®) vs Non Biological Mesh (TIGR®) in Immediate Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2016-12-07
Enrollment: 24
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total complication rate
timeFrame: 12 months
Secondary outcomes:
measure: Total infection rate
timeFrame: 30 days
measure: Total implant loss rate
timeFrame: 12 months
measure: Aesthetic outcome
timeFrame: 12 months
measure: HQOL
timeFrame: 12 months
Other outcomes:
measure: Cost evaluation
timeFrame: 12 months
Locations:
city: Goteborg
country: Sweden
facility: Dept . of plastic surgery
state: Västra Götaland
Study officials:
affiliation: Dept of plastic surgery Sahlgrenska University Hospital Gothenburg Sweden
name: Lars Kölby
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. Epub 2020 Jun 9.
citation: 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.
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 Reconstr Aesthet Surg. 2022 Nov;75(11):4133-4143. doi: 10.1016/j.bjps.2022.08.013. Epub 2022 Aug 23.