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The investigation is aimed at specifically demonstrating the ingrowth of newly formed vascular elements within ProFlor, a 3D dynamic responsive implant for inguinal hernia repair
Biopsy specimen were excised at defined postoperative stages from patients who underwent hernia repair with the 3D prosthesis named ProFlor. Scope of the study was to determine the presence, quantity and quality of the vascular elements ingrowth within the implant fabric. Histology revealed the presence of multiple angiogenetic clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, the detected vascular components assumed the typical aspect of mature veins and arteries complete in all components. The development of fully developed vascular structures, ingrowing together with other components of the abdominal wall already described in literature, seems to finalize a regenerative response. This kind of behavior, being the expected result from a device intended for the cure of inguinal hernia and its degenerative source, seems to be coherent with the pathogenesis of the disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short term post inguinal hernia repair with ProFlor | Determining presence and level of maturation of vascular structures in the inguinal hernia implant named ProFlor at 3-5 weeks post implantation |
| |
| Mid term post inguinal hernia repair with ProFlor | Determining presence and level of maturation of vascular structures in the inguinal hernia implant named ProFlor at 3-4 months post implantation |
| |
| Long term post inguinal hernia repair with ProFlor | Determining presence and level of maturation of vascular structures in the inguinal hernia implant named ProFlor at 6-8 months post implantation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProFlor inguinal hernia device | Device | Inguinal hernia repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor | Post-operative assessment of neo-angiogenesis within hernia implant ProFlor at short term post-implantation | 3-5 weeks post-implantation |
| Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor | Post-operative assessment of neo-angiogenesis within hernia implant ProFlor at midterm post-implantation | 3-4 months post implantation |
| Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor | Post-operative assessment of neo-angiogenesis within hernia implant ProFlor at midterm post-implantation | 6-8 months post implantation |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who underwent inguinal hernia repair with the prosthetic device named ProFlor
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Amato | University of Cagliari | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21752035 | Background | Amato G, Lo Monte AI, Cassata G, Damiano G, Romano G, Bussani R. A new prosthetic implant for inguinal hernia repair: its features in a porcine experimental model. Artif Organs. 2011 Aug;35(8):E181-90. doi: 10.1111/j.1525-1594.2011.01272.x. Epub 2011 Jul 13. | |
| 25626584 | Background | Amato G, Romano G, Agrusa A, Marasa S, Cocorullo G, Gulotta G, Goetze T, Puleio R. Biologic response of inguinal hernia prosthetics: a comparative study of conventional static meshes versus 3D dynamic implants. Artif Organs. 2015 Jan;39(1):E10-23. doi: 10.1111/aor.12416. |
| Label | URL |
|---|---|
| ProFlor inguinal hernia repair: features, procedural steps and clinical data | View source |
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Tissue specimen and histological records upon request
from actual date until December 2022
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Tissue specimens excised from ProFlor prosthesis implanted in patients who underwent inguinal hernia repair
| 30318605 | Background | Amato G, Romano G, Puleio R, Agrusa A, Goetze T, Gulotta E, Gordini L, Erdas E, Calo P. Neomyogenesis in 3D Dynamic Responsive Prosthesis for Inguinal Hernia Repair. Artif Organs. 2018 Dec;42(12):1216-1223. doi: 10.1111/aor.13286. Epub 2018 Oct 14. |
| 32169570 | Background | Amato G, Agrusa A, Puleio R, Calo P, Goetze T, Romano G. Neo-nervegenesis in 3D dynamic responsive implant for inguinal hernia repair. Qualitative study. Int J Surg. 2020 Apr;76:114-119. doi: 10.1016/j.ijsu.2020.02.046. Epub 2020 Mar 10. |