Neo-angiogenesis in Inguinal Henia Implant ProFlor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2020-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Inguinal Hernia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Short term post inguinal hernia repair with ProFlor

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

ProFlor inguinal hernia device

Intervention Type DEVICE

Inguinal hernia repair

Mid term post inguinal hernia repair with ProFlor

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

ProFlor inguinal hernia device

Intervention Type DEVICE

Inguinal hernia repair

Long term post inguinal hernia repair with ProFlor

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

ProFlor inguinal hernia device

Intervention Type DEVICE

Inguinal hernia repair

Interventions

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ProFlor inguinal hernia device

Inguinal hernia repair

Intervention Type DEVICE

Eligibility Criteria

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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