Closed or Open Abdomen for the Management of Abdominal Sepsis

Launched by UNIVERSITY OF CALGARY · May 19, 2017

Keywords

ClinConnect Summary

This clinical trial is studying two different methods for treating a serious condition called abdominal sepsis, which is an infection in the abdomen that can be life-threatening. The trial will randomly assign participants to one of two groups: one group will have their abdomen closed after surgery (this is called the CLOSED approach), while the other group will have their abdomen left open and covered with a temporary device that helps manage the infection (this is known as the OPEN approach). Both methods are currently accepted treatments, but the trial aims to gather better information to help doctors make the best choice for their patients.

To be eligible for this trial, participants must be between the ages of 65 and 74 and have specific signs of a severe abdominal infection, such as a significant amount of infected fluid in the abdomen or symptoms indicating severe illness. People who are pregnant, have certain serious conditions, or are not planning to continue receiving medical care cannot participate. Those who join the trial can expect to receive close monitoring and care while doctors assess which treatment method is more effective in managing their condition. This research is important because it will provide valuable insights that could help improve outcomes for patients with abdominal infections.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Presence of purulent, feculent, or enteric spillage over at least 2 intra-peritoneal quadrants intra-operatively;
• • Septic shock, or
• • Predisposition-Infection-Response-Organ Dysfunction Score \> 3, or
• • World-Society-of-Emergency-Surgery-Sepsis-Severity-Score \> 8
• Exclusion Criteria:
• • Pregnant;
• • Confirmed or strongly suspected severe IAH (IAP\>20 mmHg);
• • No intentional of providing ongoing care;
• • pancreatitis as the source of peritonitis;
• • uncontrolled bleeding