Neo-angiogenesis in Inguinal Henia Implant ProFlor

Completed

• Conditions: Inguinal Hernia
• Interventions: Device: ProFlor inguinal hernia device

• Registration Number: NCT04541316
• Lead Sponsor: University of Cagliari

Brief Summary

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

Detailed 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 vascular elements ingrowth within the implant fabric. Histology revealed the presence of multiple angiogenetic clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, the detected vascular components assumed the typical aspect of mature veins and arteries complete in all components. The development of fully developed vascular structures, ingrowing 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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2020-01
• Study Completion: 2020-07
• Status Verified: 2020-09
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Last Update Submitted: 2020-09-08
• Study First Posted: 2020-09-09
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients who underwent inguinal hernia repair with the 3D dynamic responsive device named ProFlor
• Patients undergoing recurrent inguinal hernia repair after primary repair with the 3D dynamic responsive device named ProFlor
• Patients undergoing surgical procedure in the groin area after inguinal hernia repair with the 3D dynamic responsive device named ProFlor

Exclusion Criteria

• immunosoppressive therapy, > ASA 4 classification

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mid term post inguinal hernia repair with ProFlor	ProFlor inguinal hernia device	Determining presence and level of maturation of vascular structures in the inguinal hernia implant named ProFlor at 3-4 months post implantation
Short term post inguinal hernia repair with ProFlor	ProFlor inguinal hernia device	Determining presence and level of maturation of vascular structures in the inguinal hernia implant named ProFlor at 3-5 weeks post implantation
Long term post inguinal hernia repair with ProFlor	ProFlor inguinal hernia device	Determining presence and level of maturation of vascular structures in the inguinal hernia implant named ProFlor at 6-8 months post implantation

Primary Outcome Measures

Name	Time	Method
Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor	6-8 months post implantation	Post-operative assessment of neo-angiogenesis within hernia implant ProFlor at midterm post-implantation