Evidence of Myogenic Growth Factors in 3D Dynamic Inguinal Hernia Scaffold ProFlor

Study Overview
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Brief Summary
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The study utilizes the same tissue specimens gathered for previous investigations and removed from 15 patients already operated for inguinal hernia, who for different reasons needed additional surgery in the previously operated groin.

Detailed Description
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Among the individual of investigated the cohort, seven patients underwent groin revision for subsequent hydrocele, 4 for recurrence, and 4 for overlooked ipsilateral multiple hernia protrusions. Made from low weight, large porous polypropylene, ProFlor is composed of a multilamellar cylindrical 3D core, 15 mm thick, with 2 different longitudinal dimensions, 25 or 40 mm. The center of the implant core is connected on one surface to a flat mesh of different width depending on the dimension of the 3D core. This flat part of the device is intended to be deployed to counterface the peritoneal sheath. The 3D core of ProFlor ® is arranged to be compressible on both planes, longitudinal and transversal. Due to its proprietary centrifugal expansion, it can be positioned, fixation free, into the hernia defect for permanent obliteration. ProFlor owns an inherent dynamic responsivity as it contracts and relaxes in accord to the movements of the inguinal floor in which is positioned. The biopsies were excised from the anterior aspect of the 3D device. It should be noted that once deployed the anterior surface of ProFlor merely faces the external oblique fascia and has no contact with other structures of the groin. Therefore, corruption by host native tissue can be excluded. The biopsies were carried out in ten patients, three in the short term postop. between 3 and 5 weeks, five in the mid-term between 3 and 4 months postop., four in the long-term between 6 and 8 months postop. and the latter three in the extra-long term postop., more than three years after implantation.

Official Title
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Dynamic Responsivity of Inguinal Hernia Scaffold ProFlor Attracts Myogenetic Growth Factors Finalizing the Regeneration of the Herniated Groin

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Procedure: Inguinal hernia repair with dynamic prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients already operated for inguinal hernia with ProFlor, who for different reasons needed additional surgery in the previously operated groin ASA score >4 Exclusion Criteria: Patients who do not underwent inguinal hernia repair with ProFlor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biopsies from 3D hernia scaffold ProFlor in the short term<br>3 patients biopsied 3-5 weeks post implantation of ProFlor | Procedure: Inguinal hernia repair with dynamic prosthesis<br>* Tissue specimens excised at the above defined postoperative stages were fixed in neutral-buffered 10% formalin and routinely processed to paraffin wax. Sections (4 μm thick) were cut and stored at room temperature until use. Sections were stained with hematoxylin and eosin (H&E) for histological analysis and Azan trichrome (Bioptica) staining to evaluate muscular tissue in the implant fabric.<br>|
| Biopsies from 3D hernia scaffold ProFlor in the midterm<br>5 patients biopsied 3-4 months post implantation of ProFlor | Procedure: Inguinal hernia repair with dynamic prosthesis<br>* Tissue specimens excised at the above defined postoperative stages were fixed in neutral-buffered 10% formalin and routinely processed to paraffin wax. Sections (4 μm thick) were cut and stored at room temperature until use. Sections were stained with hematoxylin and eosin (H&E) for histological analysis and Azan trichrome (Bioptica) staining to evaluate muscular tissue in the implant fabric.<br>|
| Biopsies from 3D hernia scaffold ProFlor in the long term<br>4 patients biopsied between 3-4 months post implantation of ProFlor | Procedure: Inguinal hernia repair with dynamic prosthesis<br>* Tissue specimens excised at the above defined postoperative stages were fixed in neutral-buffered 10% formalin and routinely processed to paraffin wax. Sections (4 μm thick) were cut and stored at room temperature until use. Sections were stained with hematoxylin and eosin (H&E) for histological analysis and Azan trichrome (Bioptica) staining to evaluate muscular tissue in the implant fabric.<br>|
| Biopsies from 3D hernia scaffold ProFlor in the extra long term<br>3 patients biopsied more than 3 years after implantation of ProFlor | Procedure: Inguinal hernia repair with dynamic prosthesis<br>* Tissue specimens excised at the above defined postoperative stages were fixed in neutral-buffered 10% formalin and routinely processed to paraffin wax. Sections (4 μm thick) were cut and stored at room temperature until use. Sections were stained with hematoxylin and eosin (H&E) for histological analysis and Azan trichrome (Bioptica) staining to evaluate muscular tissue in the implant fabric.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of NGF stained areas | evidence in ProFlor of NGF in the short term post implantation | 3-5 weeks postop | 
| assessment of NGF stained areas | evidence of NGF in the midterm post implantation of ProFlor | 3-4 months postop. | 
| assessment of NGF stained areas | evidence in ProFlor of NGF in the long term post implantation | 6-8 months post implantation | 
| assessment of NGF stained areas | evidence in ProFlor of NGF in the extra long term post implantation | >3 years post implantation of ProFlor | 
| assessment of NGFR p75 stained areas | evidence in ProFlor of NGFR p75 in the short term post implantation | 3-5 weeks postop | 
| assessment of NGFR p75 stained areas | evidence in ProFlor of NGFR p75 in the midterm post implantation | 3-4 months postop. | 
| assessment of NGFR p75 stained areas | evidence in ProFlor of NGFR p75 in the long term post implantation | 6-8 months post implantation | 
| assessment of NGFR p75 stained areas | evidence in ProFlor of NGFR p75 in the extra long term post implantation | >3 years post implantation of ProFlor |