Neo-nervegenesis in Inguinal Hernia Implant ProFlor

University of Cagliari

Status: Completed

Conditions: Inguinal Hernia

Treatments: Device: ProFlor Hernia implant

Study type: Interventional

Funder types: Other

Identifiers

NCT04171102

Neo-nervegenesis in ProFlor

Details and patient eligibility

About

The investigation is aimed at specifically demonstrating the ingrowth of newly formed nervous elements within a 3D dynamic responsive implant for inguinal hernia repair.

Full description

Biopsy specimen were excised at defined postoperative stages from patients who underwent hernia repair with the 3D prosthesis named ProFlor. Scope of the study was to determine the presence, quantity and quality of the neural ingrowth within the implant fabric. Histology revealed the presence of multiple nerve clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, neural elements assumed the typical aspect of normal nervous structures complete in all components. The development of highly specialized tissue such as nerves, together with other components of the abdominal wall already described in literature, seems to finalize a regenerative response. This kind of behavior, being the expected result from a device intended for the cure of inguinal hernia and its degenerative source, seems to be coherent with the pathogenesis of the disease.

Enrollment: 15 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients who underwent inguinal hernia repair with the prosthetic device named ProFlor
• Patients undergoing recurrent inguinal hernia repair after primary repair with the prosthetic device named ProFlor
• Patients undergoing surgical procedure in the groin area after inguinal hernia repair with the prosthetic device named ProFlor

Exclusion criteria

• Patients who underwent inguinal hernia repair with conventional flat meshes

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

---

15 participants in 3 patient groups

Short term post inguinal hernia repair wit ProFlor

Active Comparator group

Description:

Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 3-5 weeks post implantation

Treatment:

Device: ProFlor Hernia implant

Mid term post inguinal hernia repair wit ProFlor

Active Comparator group

Description:

Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 3-4 months post implantation

Treatment:

Device: ProFlor Hernia implant

Long term post inguinal hernia repair wit ProFlor

Active Comparator group

Description:

Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 6-8 months post implantation

Treatment:

Device: ProFlor Hernia implant