Status:
COMPLETED
Assessment of Peritoneal Immune Response in Patients With Severe Intra-abdominal Sepsis Managed With Laparostomy and Vacuum Assisted Closure (VAC)
Lead Sponsor:
Aristotle University Of Thessaloniki
Conditions:
Abdominal Sepsis
Eligibility:
All Genders
18+ years
Brief Summary
Protocol Synopsis Protocol title: Assessment of peritoneal immune response in patients with severe intra-abdominal sepsis managed by laparostomy and VAC Purpose: Assessment of peritoneal immune resp...
Detailed Description
Principal Investigator Statement: ……………………………………………… 1 Protocol Synopsis: ……………………………………………………………… 2 Table of Content: ………………………………………………………………. .4 1.0 Introduction: ……………………………………………………………. 5 2.0 Tec...
Eligibility Criteria
Inclusion
- Patient \> 18 years old
- 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.
- Patient or relatives signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures
Exclusion
- Patient's Manheim Peritonitis Score \< 29
- Patient's pre-operative SOFA score \< 6
- The use of other temporary abdominal closure system
- Decease before the first VAC dressing change
- Patient is participating in another clinical trial which may affect this study's outcomes
- Patients with immune deficiency
- Documented seropositivity for human immunodeficiency virus (AIDS)
- Patient receiving steroids treatment for other medical condition
- Patient receiving chronic anti-inflammatory treatment
- Patient receiving anti- TNF treatment
- Pre-existing parechymal liver disease ( Cirrhosis - Child-Pugh C)
- Pregnancy
Key Trial Info
Start Date :
May 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01410526
Start Date
May 1 2011
End Date
August 1 2015
Last Update
August 30 2021
Active Locations (1)
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1
3rd Department of Surgery, AHEPA University Hospital
Thessaloniki, Greece, 54636