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

Inguinal Hernia Clinical Trial

— HERNIA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05072171
• Other study ID #: HERNIA 01_2021
• Status: Active, not recruiting
• Start date: January 1, 2013
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2021
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 31, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Outcome

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