Evidence of Myogenic Growth Factors in 3D Dynamic Inguinal Hernia Scaffold ProFlor
NCT ID: NCT05072171
Last Updated: 2021-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
15 participants
OBSERVATIONAL
2013-01-01
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Biopsies from 3D hernia scaffold ProFlor in the short term
3 patients biopsied 3-5 weeks post implantation of ProFlor
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.
Biopsies from 3D hernia scaffold ProFlor in the midterm
5 patients biopsied 3-4 months post implantation of ProFlor
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.
Biopsies from 3D hernia scaffold ProFlor in the long term
4 patients biopsied between 3-4 months post implantation of ProFlor
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.
Biopsies from 3D hernia scaffold ProFlor in the extra long term
3 patients biopsied more than 3 years after implantation of ProFlor
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* ASA score \>4
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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University of Palermo
OTHER
Responsible Party
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Prof. Antonino Agrusa
Associated professor
Principal Investigators
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Antonino Agrusa, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Palermo - Italy
Other Identifiers
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HERNIA 01_2021
Identifier Type: -
Identifier Source: org_study_id