Neo-angiogenesis in Inguinal Henia Implant ProFlor

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

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ProFlor inguinal hernia device

Device

Inguinal hernia repair

Primary outcomes

Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor

Time frame: 3-5 weeks post-implantation

Post-operative assessment of neo-angiogenesis within hernia implant ProFlor at short term post-implantation
Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor

Time frame: 3-4 months post implantation

Post-operative assessment of neo-angiogenesis within hernia implant ProFlor at midterm post-implantation
Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor

Time frame: 6-8 months post implantation

Post-operative assessment of neo-angiogenesis within hernia implant ProFlor at midterm post-implantation

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Registry information

Official study title

Neo-angiogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair ProFlor

Important dates

Study start: 2013
Primary completion: 2020
Study completion: 2020
First posted: Sep 9, 2020
Registry last updated: Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed