Neo-nervegenesis in Inguinal Hernia Implant ProFlor

Overview

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

Full Title of Study: “Neo-neurogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair PorFlor”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2016

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.

Interventions

  • Device: ProFlor Hernia implant
    • Inguinal hernia repair

Arms, Groups and Cohorts

  • 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
  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor
    • Time Frame: 3 weeks until 8 months post-implantation
    • Post-operative assessment of neonervegenesis within hernia implant ProFlor at short, mid and long term post-implantation

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Cagliari
  • Provider of Information About this Clinical Study
    • Principal Investigator: Giuseppe Amato, Consultant Professor – University of Cagliari
  • Overall Official(s)
    • Giuseppe Amato, MD, Principal Investigator, University of Cagliari

References

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, Calò 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.

Citations Reporting on Results

Amato G, Agrusa A, Puleio R, Calò 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.

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