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临床试验/NCT05072171
NCT05072171Unknown不适用

Dynamic Responsivity of Inguinal Hernia Scaffold ProFlor Attracts Myogenetic Growth Factors Finalizing the Regeneration of the Herniated Groin

University of Palermo0 个研究点目标入组 15 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
主要终点
assessment of NGF stained areas

研究概览

简要总结

The study utilizes the same tissue specimens gathered for previous investigations and removed from 15 patients already operated for inguinal hernia, who for different reasons needed additional surgery in the previously operated groin.

详细描述

Among the individual of investigated the cohort, seven patients underwent groin revision for subsequent hydrocele, 4 for recurrence, and 4 for overlooked ipsilateral multiple hernia protrusions. Made from low weight, large porous polypropylene, ProFlor is composed of a multilamellar cylindrical 3D core, 15 mm thick, with 2 different longitudinal dimensions, 25 or 40 mm. The center of the implant core is connected on one surface to a flat mesh of different width depending on the dimension of the 3D core. This flat part of the device is intended to be deployed to counterface the peritoneal sheath. The 3D core of ProFlor ® is arranged to be compressible on both planes, longitudinal and transversal. Due to its proprietary centrifugal expansion, it can be positioned, fixation free, into the hernia defect for permanent obliteration. ProFlor owns an inherent dynamic responsivity as it contracts and relaxes in accord to the movements of the inguinal floor in which is positioned.

The biopsies were excised from the anterior aspect of the 3D device. It should be noted that once deployed the anterior surface of ProFlor merely faces the external oblique fascia and has no contact with other structures of the groin. Therefore, corruption by host native tissue can be excluded. The biopsies were carried out in ten patients, three in the short term postop. between 3 and 5 weeks, five in the mid-term between 3 and 4 months postop., four in the long-term between 6 and 8 months postop. and the latter three in the extra-long term postop., more than three years after implantation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients already operated for inguinal hernia with ProFlor, who for different reasons needed additional surgery in the previously operated groin
  • ASA score >4

排除标准

  • Patients who do not underwent inguinal hernia repair with ProFlor

结局指标

主要结局

assessment of NGF stained areas

时间窗: >3 years post implantation of ProFlor

evidence in ProFlor of NGF in the extra long term post implantation

assessment of NGFR p75 stained areas

时间窗: >3 years post implantation of ProFlor

evidence in ProFlor of NGFR p75 in the extra long term post implantation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Antonino Agrusa

Associated professor

University of Palermo

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