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

Aristotle University Of Thessaloniki · 2011
ClinicalTrials.gov · Datasets · License: Public Domain · 2011
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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 response in patients with severe intra-abdominal sepsis Design: Prospective, single-center study Patient Population: Male or female adults (\>18 years) with severe intra-abdominal sepsis No. of Subjects: 60 patients divided into two groups, 30 patients with severe intra-operative sepsis and 30 patients without sepsis scheduled to undergo major abdominal operations (middle line incision\>15cm). The study is estimated up to 2 year to enroll Duration of Follow-up: Follow-up will be performed daily while hospitalized, until patient discharged or deceased. Endpoints: 1. To measure the peritoneal cytokines levels in patients with severe intra-abdominal sepsis. 2. To correlate the cytokines levels in the abdominal cavity and the serum plasma. 3. To correlate cytokines response in serum plasma and peritoneal fluid with mortality and morbidity. 4. To compare cytokines results in serum plasma and peritoneal fluid between patients with severe intra-abdominal sepsis and patients undergoing major laparotomy without sepsis. 5. To assess the microbial load in the abdominal cavity in patients with severe sepsis. 6. To assess the biofilm formation in VAC polyurethane sponge.
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