Clinical trial NCT05072171: Evidence of Myogenic Growth Factors in 3D Dynamic Inguinal Hernia Scaffold ProFlor
Official title: Dynamic Responsivity of Inguinal Hernia Scaffold ProFlor Attracts Myogenetic Growth Factors Finalizing the Regeneration of the Herniated Groin
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inguinal Hernia
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* patients already operated for inguinal hernia with ProFlor, who for different reasons needed additional surgery in the previously operated groin
* ASA score \>4

Exclusion Criteria:

* Patients who do not underwent inguinal hernia repair with ProFlor

Primary outcomes:
measure: assessment of NGF stained areas
timeFrame: 3-5 weeks postop
measure: assessment of NGF stained areas
timeFrame: 3-4 months postop.
measure: assessment of NGF stained areas
timeFrame: 6-8 months post implantation
measure: assessment of NGF stained areas
timeFrame: >3 years post implantation of ProFlor
measure: assessment of NGFR p75 stained areas
timeFrame: 3-5 weeks postop
measure: assessment of NGFR p75 stained areas
timeFrame: 3-4 months postop.
measure: assessment of NGFR p75 stained areas
timeFrame: 6-8 months post implantation
measure: assessment of NGFR p75 stained areas
timeFrame: >3 years post implantation of ProFlor
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Palermo - Italy
name: Antonino Agrusa, Professor
role: PRINCIPAL_INVESTIGATOR
References: