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This study compares the outcome using a biological mesh (Veritas®) compared to a non biological mesh (TIGR®) in immediate breast reconstruction.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veritas® mesh | Experimental | Use of Veritas mesh in conjunction with immediate breast reconstruction on one side |
|
| TIGR® mesh | Experimental | Use of TIGR® mesh in conjunction with immediate breast reconstruction on one side |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veritas® | Device | Biologic mesh |
| |
| TIGR® |
| Measure | Description | Time Frame |
|---|---|---|
| Total complication rate | Total complication rate within one year from surgery | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total infection rate | Total infection rate within 30 days from surgery | 30 days |
| Total implant loss rate | Total implant loss rate within one year from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Kölby | Dept of plastic surgery Sahlgrenska University Hospital Gothenburg Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept . of plastic surgery | Gothenburg | Västra Götaland County | 41345 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31859575 | Result | 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. | |
| 32515840 | Result |
| Label | URL |
|---|---|
| Full text article | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Device |
Non biologic mesh |
|
| 12 months |
| 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 |
| 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 |
| 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. |
| 33051871 | Result | 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. |
| 36154981 | Result | 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. |
| Full text article | View source |
| Full text article | View source |
| D017437 |
| Skin and Connective Tissue Diseases |