Neo-nervegenesis in Inguinal Hernia 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 nervous elements within 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 neural ingrowth within the implant fabric. Histology revealed the presence of multiple nerve clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, neural elements assumed the typical aspect of normal nervous structures complete in all components. The development of highly specialized tissue such as nerves, 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-neurogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair PorFlor

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Device: ProFlor Hernia implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent inguinal hernia repair with the prosthetic device named ProFlor Patients undergoing recurrent inguinal hernia repair after primary repair with the prosthetic device named ProFlor Patients undergoing surgical procedure in the groin area after inguinal hernia repair with the prosthetic device named ProFlor Exclusion Criteria: Patients who underwent inguinal hernia repair with conventional flat meshes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Short term post inguinal hernia repair wit ProFlor<br>Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 3-5 weeks post implantation | Device: ProFlor Hernia implant<br>* Inguinal hernia repair<br>|
| Active Comparator: Mid term post inguinal hernia repair wit ProFlor<br>Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 3-4 months post implantation | Device: ProFlor Hernia implant<br>* Inguinal hernia repair<br>|
| Active Comparator: Long term post inguinal hernia repair wit ProFlor<br>Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 6-8 months post implantation | Device: ProFlor Hernia implant<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 Nervous Elements Within Hernia Implant ProFlor | Post-operative assessment of neonervegenesis within hernia implant ProFlor at short, mid and long term post-implantation | 3 weeks until 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-nervegenesis, Regenerative scaffold