Neo-angiogenesis in Inguinal Henia Implant ProFlor

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Neo-angiogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair ProFlor

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Device: ProFlor inguinal hernia device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent inguinal hernia repair with the 3D dynamic responsive device named ProFlor Patients undergoing recurrent inguinal hernia repair after primary repair with the 3D dynamic responsive device named ProFlor Patients undergoing surgical procedure in the groin area after inguinal hernia repair with the 3D dynamic responsive device named ProFlor Exclusion Criteria: immunosoppressive therapy, > ASA 4 classification

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Short term post inguinal hernia repair with ProFlor<br>Determining presence and level of maturation of vascular structures in the inguinal hernia implant named ProFlor at 3-5 weeks post implantation | Device: ProFlor inguinal hernia device<br>* Inguinal hernia repair<br>|
| Mid term post inguinal hernia repair with ProFlor<br>Determining presence and level of maturation of vascular structures in the inguinal hernia implant named ProFlor at 3-4 months post implantation | Device: ProFlor inguinal hernia device<br>* Inguinal hernia repair<br>|
| Long term post inguinal hernia repair with ProFlor<br>Determining presence and level of maturation of vascular structures in the inguinal hernia implant named ProFlor at 6-8 months post implantation | Device: ProFlor inguinal hernia device<br>* Inguinal hernia repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hernia implants, Biologic response, Neo-angiogenesis, Regenerative scaffolds