Assessment of Peritoneal Immune Response in Patients With Severe Intra-abdominal Sepsis Managed With Laparostomy and Vacuum Assisted Closure (VAC)

Launched by ARISTOTLE UNIVERSITY OF THESSALONIKI · Aug 4, 2011

Keywords

ClinConnect Summary

Principal Investigator Statement: ...................................................... 1 Protocol Synopsis: ........................................................................ 2 Table of Content: ......................................................................... .4 1.0 Introduction: ...................................................................... 5 2.0 Techniques descriptions: ........................................................ 6 3.0 Objectives: ..........................................................................7 4.0 Design and study population: ................

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient \> 18 years old
• • 2. 30 patients with severe abdominal sepsis in order to form the study group and 30 patients without sepsis undergoing major elective surgery (middle line incision \>15cm) to form the control group.
• • 3. Patient or relatives signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures
• Exclusion Criteria:
• • 1. Patient's Manheim Peritonitis Score \< 29
• • 2. Patient's pre-operative SOFA score \< 6
• • 3. The use of other temporary abdominal closure system
• • 4. Decease before the first VAC dressing change
• • 5. Patient is participating in another clinical trial which may affect this study's outcomes
• • 6. Patients with immune deficiency
• • 7. Documented seropositivity for human immunodeficiency virus (AIDS)
• • 8. Patient receiving steroids treatment for other medical condition
• • 9. Patient receiving chronic anti-inflammatory treatment
• • 10. Patient receiving anti- TNF treatment
• • 11. Pre-existing parechymal liver disease ( Cirrhosis - Child-Pugh C)
• • 12. Pregnancy