Clinical trial NCT04762264: MR Imaging of the 3D Inguinal Hernia Scaffold ProFlor
Official title: A 3D Regenerative Scaffold for Inguinal Hernia Repair. MR Imaging and Histological Cross Evidence.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: Demonstrating through MRI sequuences the regenerative features of the 3D inguinal hernia scaffold ProFlor

Detailed description: The biological response of the 3D inguinal hernia scaffold ProFlor has been evaluated through MRI signal intensity (SI) at three defined post-implantation stages: short, mid and long term. The SI of ProFlor has been compared to the SI of the neighbouring muscles and fat. As additional proof, histology of tissue specimens excised at the identical post-implantation stages from porcine models in the fame of a previous experimental attempt were also evaluated. The results of this experimental trial have ben already published in 2011 - ref: A new prosthetic implant for inguinal hernia repair: its features in a porcine experimental model. Artificial Organs 2011;35(8):E181-E190

Eligibility criteria: Inclusion Criteria:

* patients who underwent inguinal hernia repair with the 3D inguinal hernia scaffold ProFlor

Exclusion Criteria:

* all individuals who underwent inguinal hernia repair withouth the 3D inguinal hernia scaffold ProFlor

Primary outcomes:
measure: tissue incorporation into ProFlor in the short term postop.
timeFrame: 1- 3 weeks post implantation
measure: tissue incorporation into ProFlor in the mid term postop.
timeFrame: 4-7 months post implantation
measure: tissue incorporation into ProFlor in the long term postop.
timeFrame: 8 months post implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: University of Palermo - Italy
Study officials:
affiliation: University of Cagliari
name: Giuseppe Amato
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.