Inguinal HerniaHERNIANCT05072171
Evidence of Myogenic Growth Factors in 3D Dynamic Inguinal Hernia Scaffold ProFlor
An observational study of Inguinal Hernia, run by University of Palermo.
Trial summary
The study utilizes the same tissue specimens gathered for previous investigations and removed from 15 patients already operated for inguinal hernia, who for different reasons needed additional surgery in the previously operated groin. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Inguinal hernia repair with dynamic prosthesis
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Biopsies from ProFlor carried out in 15 patients: 3 in the short term postop. between 3-5 weeks, 5 in the mid-term between 3-4 months postop., 4 in the long-term between 6-8 months postop. and the latter 3 in the extra-long term postop., more than 3 years after implantation
Who may be able to join
- patients already operated for inguinal hernia with ProFlor, who for different reasons needed additional surgery in the previously operated groin
- ASA score >4
Who cannot join
- Patients who do not underwent inguinal hernia repair with ProFlor
About this study
Official title: Dynamic Responsivity of Inguinal Hernia Scaffold ProFlor Attracts Myogenetic Growth Factors Finalizing the Regeneration of the Herniated Groin
The study utilizes the same tissue specimens gathered for previous investigations and removed from 15 patients already operated for inguinal hernia, who for different reasons needed additional surgery in the previously operated groin.
Read the detailed description
Among the individual of investigated the cohort, seven patients underwent groin revision for subsequent hydrocele, 4 for recurrence, and 4 for overlooked ipsilateral multiple hernia protrusions. Made from low weight, large porous polypropylene, ProFlor is composed of a multilamellar cylindrical 3D core, 15 mm thick, with 2 different longitudinal dimensions, 25 or 40 mm. The center of the implant core is connected on one surface to a flat mesh of different width depending on the dimension of the 3D core. This flat part of the device is intended to be deployed to counterface the peritoneal sheath. The 3D core of ProFlor ® is arranged to be compressible on both planes, longitudinal and transversal. Due to its proprietary centrifugal expansion, it can be positioned, fixation free, into the hernia defect for permanent obliteration. ProFlor owns an inherent dynamic responsivity as it contracts and relaxes in accord to the movements of the inguinal floor in which is positioned.
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
- Inguinal Hernia
- Being tested
- Inguinal hernia repair with dynamic prosthesis
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inguinal hernia repair with dynamic prosthesisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Biopsies from 3D hernia scaffold ProFlor in the short term | 3 patients biopsied 3-5 weeks post implantation of ProFlor Receives: Procedure: Inguinal hernia repair with dynamic prosthesis | |
| Biopsies from 3D hernia scaffold ProFlor in the midterm | 5 patients biopsied 3-4 months post implantation of ProFlor Receives: Procedure: Inguinal hernia repair with dynamic prosthesis | |
| Biopsies from 3D hernia scaffold ProFlor in the long term | 4 patients biopsied between 3-4 months post implantation of ProFlor Receives: Procedure: Inguinal hernia repair with dynamic prosthesis | |
| Biopsies from 3D hernia scaffold ProFlor in the extra long term | 3 patients biopsied more than 3 years after implantation of ProFlor Receives: Procedure: Inguinal hernia repair with dynamic prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of NGF stained areas
evidence in ProFlor of NGF in the short term post implantation
Measured: 3-5 weeks postop
assessment of NGF stained areas
evidence of NGF in the midterm post implantation of ProFlor
Measured: 3-4 months postop.
assessment of NGF stained areas
evidence in ProFlor of NGF in the long term post implantation
Measured: 6-8 months post implantation
assessment of NGF stained areas
evidence in ProFlor of NGF in the extra long term post implantation
Measured: >3 years post implantation of ProFlor
assessment of NGFR p75 stained areas
evidence in ProFlor of NGFR p75 in the short term post implantation
Measured: 3-5 weeks postop
assessment of NGFR p75 stained areas
evidence in ProFlor of NGFR p75 in the midterm post implantation
Measured: 3-4 months postop.
assessment of NGFR p75 stained areas
evidence in ProFlor of NGFR p75 in the long term post implantation
Measured: 6-8 months post implantation
assessment of NGFR p75 stained areas
evidence in ProFlor of NGFR p75 in the extra long term post implantation
Measured: >3 years post implantation of ProFlor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start1 Jan 2013
- Primary completion1 Sep 2021
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Antonino Agrusa, University of Palermo
- Investigators
- Antonino Agrusa, Professor, Principal investigator, University of Palermo - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072171
- Sponsor's protocol ID
- HERNIA 01_2021
- Acronym
- HERNIA
- Status last verified
- Oct 2021
- First submitted
- 16 Sep 2021
- Last updated
- 18 Oct 2021
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Responsivity of Inguinal Hernia Scaffold ProFlor Attracts Myogenetic Growth Factors Finalizing the Regeneration of the Herniated Groin
- ClinicalTrials.gov ID
- NCT05072171
- Acronym / sponsor ID
- HERNIA / HERNIA 01_2021
- Conditions
- Inguinal Hernia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study utilizes the same tissue specimens gathered for previous investigations and removed from 15 patients already operated for inguinal hernia, who for different reasons needed additional surgery in the previously operated groin.
Detailed description
Among the individual of investigated the cohort, seven patients underwent groin revision for subsequent hydrocele, 4 for recurrence, and 4 for overlooked ipsilateral multiple hernia protrusions. Made from low weight, large porous polypropylene, ProFlor is composed of a multilamellar cylindrical 3D core, 15 mm thick, with 2 different longitudinal dimensions, 25 or 40 mm. The center of the implant core is connected on one surface to a flat mesh of different width depending on the dimension of the 3D core. This flat part of the device is intended to be deployed to counterface the peritoneal sheath. The 3D core of ProFlor ® is arranged to be compressible on both planes, longitudinal and transversal. Due to its proprietary centrifugal expansion, it can be positioned, fixation free, into the hernia defect for permanent obliteration. ProFlor owns an inherent dynamic responsivity as it contracts and relaxes in accord to the movements of the inguinal floor in which is positioned.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Biopsies from 3D hernia scaffold ProFlor in the short term | – | Procedure: Inguinal hernia repair with dynamic prosthesis3 patients biopsied 3-5 weeks post implantation of ProFlor |
| Biopsies from 3D hernia scaffold ProFlor in the midterm | – | Procedure: Inguinal hernia repair with dynamic prosthesis5 patients biopsied 3-4 months post implantation of ProFlor |
| Biopsies from 3D hernia scaffold ProFlor in the long term | – | Procedure: Inguinal hernia repair with dynamic prosthesis4 patients biopsied between 3-4 months post implantation of ProFlor |
| Biopsies from 3D hernia scaffold ProFlor in the extra long term | – | Procedure: Inguinal hernia repair with dynamic prosthesis3 patients biopsied more than 3 years after implantation of ProFlor |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Biopsies from ProFlor carried out in 15 patients: 3 in the short term postop. between 3-5 weeks, 5 in the mid-term between 3-4 months postop., 4 in the long-term between 6-8 months postop. and the latter 3 in the extra-long term postop., more than 3 years after implantation
Key inclusion criteria (2 listed)
- patients already operated for inguinal hernia with ProFlor, who for different reasons needed additional surgery in the previously operated groin
- ASA score >4
Key exclusion criteria (1 listed)
- Patients who do not underwent inguinal hernia repair with ProFlor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inguinal hernia repair with dynamic prosthesisTissue 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. | Procedure or surgery | Biopsies from 3D hernia scaffold ProFlor in the extra long term, Biopsies from 3D hernia scaffold ProFlor in the long term, Biopsies from 3D hernia scaffold ProFlor in the midterm, Biopsies from 3D hernia scaffold ProFlor in the short term |
Primary outcome
assessment of NGF stained areas
Time frame: 3-5 weeks postop
evidence in ProFlor of NGF in the short term post implantation
assessment of NGF stained areas
Time frame: 3-4 months postop.
evidence of NGF in the midterm post implantation of ProFlor
assessment of NGF stained areas
Time frame: 6-8 months post implantation
evidence in ProFlor of NGF in the long term post implantation
assessment of NGF stained areas
Time frame: >3 years post implantation of ProFlor
evidence in ProFlor of NGF in the extra long term post implantation
assessment of NGFR p75 stained areas
Time frame: 3-5 weeks postop
evidence in ProFlor of NGFR p75 in the short term post implantation
assessment of NGFR p75 stained areas
Time frame: 3-4 months postop.
evidence in ProFlor of NGFR p75 in the midterm post implantation
assessment of NGFR p75 stained areas
Time frame: 6-8 months post implantation
evidence in ProFlor of NGFR p75 in the long term post implantation
assessment of NGFR p75 stained areas
Time frame: >3 years post implantation of ProFlor
evidence in ProFlor of NGFR p75 in the extra long term post implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonino Agrusa, Professor principal investigator
University of Palermo - Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by University of Palermo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of NGF stained areas (time frame: 3-5 weeks postop). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.