Inguinal Hernia
Conditions
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
Interventions
Device follow up after inguinal hernia repair with ProFlor
Sponsors
University of Cagliari
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tissue incorporation into ProFlor in the short term postop. | 1- 3 weeks post implantation | evidencing the quality of the biologic response in ProFlor through signal intensity assessment collected in the T1 TSE axial sequence and measured with region-of-interest application (ROI) positioned on three different zones, respectively in muscle, fat and tissue ingrown within ProFlor |
| tissue incorporation into ProFlor in the mid term postop. | 4-7 months post implantation | evidencing the quality of the biologic response in ProFlor through signal intensity assessment collected in the T1 TSE axial sequence and measured with region-of-interest application (ROI) positioned on three different zones, respectively in muscle, fat and tissue ingrown within ProFlor |
| tissue incorporation into ProFlor in the long term postop. | 8 months post implantation | evidencing the quality of the biologic response in ProFlor through signal intensity assessment collected in the T1 TSE axial sequence and measured with region-of-interest application (ROI) positioned on three different zones, respectively in muscle, fat and tissue ingrown within ProFlor |
Countries
Italy
Outcome results
None listed