Evidence of Myogenic Growth Factors in 3D Dynamic Inguinal Hernia Scaffold ProFlor

NCT05072171 | Unknown

• 1 other identifier: HERNIA 01_2021
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (8)

• assessment of NGF stained areas

  evidence in ProFlor of NGF in the short term post implantation

  3-5 weeks postop

• assessment of NGF stained areas

  evidence of NGF in the midterm post implantation of ProFlor

  3-4 months postop.

• assessment of NGF stained areas

  evidence in ProFlor of NGF in the long term post implantation

  6-8 months post implantation

• assessment of NGF stained areas

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

  >3 years post implantation of ProFlor

• assessment of NGFR p75 stained areas

  evidence in ProFlor of NGFR p75 in the short term post implantation

  3-5 weeks postop

• assessment of NGFR p75 stained areas

  evidence in ProFlor of NGFR p75 in the midterm post implantation

  3-4 months postop.

• assessment of NGFR p75 stained areas

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

  6-8 months post implantation

• assessment of NGFR p75 stained areas

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

  >3 years post implantation of ProFlor

Study Arms (4)

Biopsies from 3D hernia scaffold ProFlor in the short term

3 patients biopsied 3-5 weeks post implantation of ProFlor

Procedure: Inguinal hernia repair with dynamic prosthesis

Biopsies from 3D hernia scaffold ProFlor in the midterm

5 patients biopsied 3-4 months post implantation of ProFlor

Procedure: Inguinal hernia repair with dynamic prosthesis

Biopsies from 3D hernia scaffold ProFlor in the long term

4 patients biopsied between 3-4 months post implantation of ProFlor

Procedure: Inguinal hernia repair with dynamic prosthesis

Biopsies from 3D hernia scaffold ProFlor in the extra long term

3 patients biopsied more than 3 years after implantation of ProFlor

Procedure: Inguinal hernia repair with dynamic prosthesis

Interventions

Inguinal hernia repair with dynamic prosthesis PROCEDURE

Tissue specimens excised at the above defined postoperative stages were fixed in neutral-buffered 10% formalin and routinely processed to paraffin wax. Sections (4 μm thick) were cut and stored at room temperature until use. Sections were stained with hematoxylin and eosin (H\&E) for histological analysis and Azan trichrome (Bioptica) staining to evaluate muscular tissue in the implant fabric.

Biopsies from 3D hernia scaffold ProFlor in the extra long term; Biopsies from 3D hernia scaffold ProFlor in the long term; Biopsies from 3D hernia scaffold ProFlor in the midterm; Biopsies from 3D hernia scaffold ProFlor in the short term

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Biopsies from ProFlor carried out in 15 patients: 3 in the short term postop. between 3-5 weeks, 5 in the mid-term between 3-4 months postop., 4 in the long-term between 6-8 months postop. and the latter 3 in the extra-long term postop., more than 3 years after implantation

You may qualify if:

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

You may not qualify if:

• Patients who do not underwent inguinal hernia repair with ProFlor

Sponsors & Collaborators

• University of Palermo: lead

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

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

Study Officials

• Antonino Agrusa, Professor

  University of Palermo - Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 8, 2021
• Study Start: January 1, 2013
• Primary Completion: September 1, 2021
• Study Completion: December 31, 2021
• Last Updated: October 18, 2021

Record last verified: 2021-10