NCT05072171

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: University of Palermo · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inguinal Hernia

Interventions

Type	Name	Description
PROCEDURE	Inguinal hernia repair with dynamic prosthesis	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.

Timeline

• Start date: 2013-01-01
• Primary completion: 2021-09-01
• Completion: 2021-12-31
• First posted: 2021-10-08
• Last updated: 2021-10-18