Neo-angiogenesis in Inguinal Henia Implant ProFlor

University of Cagliari

Status: Completed

Conditions: Inguinal Hernia

Treatments: Device: ProFlor inguinal hernia device

Study type: Observational

Funder types: Other

Identifiers

NCT04541316

Neo-angiogenesis in ProFlor

Details and patient eligibility

About

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

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 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

15 participants in 3 patient groups

Short term post inguinal hernia repair with ProFlor

Description:

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

Treatment:

Device: ProFlor inguinal hernia device

Mid term post inguinal hernia repair with ProFlor

Description:

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

Treatment:

Device: ProFlor inguinal hernia device

Long term post inguinal hernia repair with ProFlor

Description:

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

Treatment:

Device: ProFlor inguinal hernia device