Clinical trial NCT04541316: Neo-angiogenesis in Inguinal Henia Implant ProFlor
Official title: Neo-angiogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair ProFlor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Keywords: Hernia implants
Biologic response
Neo-angiogenesis
Regenerative scaffolds
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent inguinal hernia repair with the prosthetic device named ProFlor

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor
timeFrame: 3-5 weeks post-implantation
measure: Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor
timeFrame: 3-4 months post implantation
measure: Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor
timeFrame: 6-8 months post implantation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Cagliari
name: Giuseppe Amato
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amato G, Lo Monte AI, Cassata G, Damiano G, Romano G, Bussani R. A new prosthetic implant for inguinal hernia repair: its features in a porcine experimental model. Artif Organs. 2011 Aug;35(8):E181-90. doi: 10.1111/j.1525-1594.2011.01272.x. Epub 2011 Jul 13.
citation: Amato G, Romano G, Agrusa A, Marasa S, Cocorullo G, Gulotta G, Goetze T, Puleio R. Biologic response of inguinal hernia prosthetics: a comparative study of conventional static meshes versus 3D dynamic implants. Artif Organs. 2015 Jan;39(1):E10-23. doi: 10.1111/aor.12416.
citation: Amato G, Romano G, Puleio R, Agrusa A, Goetze T, Gulotta E, Gordini L, Erdas E, Calo P. Neomyogenesis in 3D Dynamic Responsive Prosthesis for Inguinal Hernia Repair. Artif Organs. 2018 Dec;42(12):1216-1223. doi: 10.1111/aor.13286. Epub 2018 Oct 14.
citation: Amato G, Agrusa A, Puleio R, Calo P, Goetze T, Romano G. Neo-nervegenesis in 3D dynamic responsive implant for inguinal hernia repair. Qualitative study. Int J Surg. 2020 Apr;76:114-119. doi: 10.1016/j.ijsu.2020.02.046. Epub 2020 Mar 10.