Neo-nervegenesis in Inguinal Hernia Implant ProFlor

Neo-neurogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair PorFlor

The investigation is aimed at specifically demonstrating the ingrowth of newly formed nervous elements within a 3D dynamic responsive implant for inguinal hernia repair.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Device: ProFlor Hernia implant

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Short term post inguinal hernia repair wit ProFlor; 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; Inguinal hernia repair
Active Comparator: Mid term post inguinal hernia repair wit ProFlor; 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; Inguinal hernia repair
Active Comparator: Long term post inguinal hernia repair wit ProFlor; 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; Inguinal hernia repair

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Cagliari
• Investigators: Principal Investigator: Giuseppe Amato, MD, University of Cagliari

Publications and helpful links

General Publications

• Amato G, Lo Monte AI, Cassata G, Damiano G, Romano G, Bussani R. A new prosthetic implant for inguinal hernia repair: its features in a porcine experimental model. Artif Organs. 2011 Aug;35(8):E181-90. doi: 10.1111/j.1525-1594.2011.01272.x. Epub 2011 Jul 13.
• Amato G, Romano G, Agrusa A, Marasa S, Cocorullo G, Gulotta G, Goetze T, Puleio R. Biologic response of inguinal hernia prosthetics: a comparative study of conventional static meshes versus 3D dynamic implants. Artif Organs. 2015 Jan;39(1):E10-23. doi: 10.1111/aor.12416.
• Amato G, Romano G, Puleio R, Agrusa A, Goetze T, Gulotta E, Gordini L, Erdas E, Calo P. Neomyogenesis in 3D Dynamic Responsive Prosthesis for Inguinal Hernia Repair. Artif Organs. 2018 Dec;42(12):1216-1223. doi: 10.1111/aor.13286. Epub 2018 Oct 14.
• Amato G, Agrusa A, Puleio R, Calo P, Goetze T, Romano G. Neo-nervegenesis in 3D dynamic responsive implant for inguinal hernia repair. Qualitative study. Int J Surg. 2020 Apr;76:114-119. doi: 10.1016/j.ijsu.2020.02.046. Epub 2020 Mar 10.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): June 17, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Hernia implants; Biologic response; Neo-nervegenesis; Regenerative scaffold
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: Neo-nervegenesis in ProFlor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Tissue specimen and histological records upon request
• IPD Sharing Time Frame: from actual date until december 2021
• IPD Sharing Access Criteria: personal contact

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes