FOreign body Reaction to bioMaterials and the Effect of Disease; inFORMED-trial

Completed

• Conditions: lichaamsvreemde inflammatoire reactie; foreign body reaction

• Registration Number: NL-OMON40901
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

- Body Mass Index >30 kg/m2 OR aortic aneurysm >3cm OR healthy volunteer
- > 18 years
- signed informed consent

Exclusion Criteria

- < 18 years
- BMI< 18kg/m2
- use of the following medication: immunosuppressive drugs, corticosteroids, chemotherapy recently.
- smokers
- Diabetes mellitus type I or II
- Patients who have a medical history like previous surgery or having a prosthesis e.g. heart valve, knee or hip replacement, mesh hernia repair, any kind of osteosynthesis material etcetera, all patients with any foreign body material should be excluded
- Patients who know or think that they might be infected with hepatitis B or C or HIV
- Patients with an autoimmune disease or chronic inflammatory disease.
- Patients who are anaemic or receiving treatment for anaemia or iron deficiency.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-M1/M2 index</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Gene expression of M1 and M2 markers<br /><br>- DNA levels as indication for the number of cells</p><br>