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

• Conditions: Inguinal Hernia
• Interventions: Procedure: Inguinal hernia repair with dynamic prosthesis

• Registration Number: NCT05072171
• Lead Sponsor: University of Palermo

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2021-09-01
• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-27
• Status Verified: 2021-10
• Study First Posted: 2021-10-08
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-18
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biopsies from 3D hernia scaffold ProFlor in the short term	Inguinal hernia repair with dynamic prosthesis	3 patients biopsied 3-5 weeks post implantation of ProFlor
Biopsies from 3D hernia scaffold ProFlor in the midterm	Inguinal hernia repair with dynamic prosthesis	5 patients biopsied 3-4 months post implantation of ProFlor
Biopsies from 3D hernia scaffold ProFlor in the long term	Inguinal hernia repair with dynamic prosthesis	4 patients biopsied between 3-4 months post implantation of ProFlor
Biopsies from 3D hernia scaffold ProFlor in the extra long term	Inguinal hernia repair with dynamic prosthesis	3 patients biopsied more than 3 years after implantation of ProFlor

Primary Outcome Measures

Name	Time	Method
assessment of NGF stained areas	>3 years post implantation of ProFlor	evidence in ProFlor of NGF in the extra long term post implantation
assessment of NGFR p75 stained areas	>3 years post implantation of ProFlor	evidence in ProFlor of NGFR p75 in the extra long term post implantation