Comparing closed and open abdomen techniques for treating abdominal sepsis

Closed Versus Open Abdomen in the Surgical Treatment of Severe Secondary Peritonitis: a Randomized Controlled Clinical Trial

This study is testing whether closing the abdomen after surgery or leaving it open with a special device works better for people with severe abdominal infections.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 550 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Calgary (other)
• Locations: 1 site (Calgary, Alberta)
• Trial ID: NCT03163095 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare two surgical approaches for managing severe complicated intra-abdominal sepsis: primarily closing the fascia after laparotomy versus leaving the fascia open and applying a temporary abdominal closure device with vacuum drainage. The study will randomly assign participants to one of the two treatment groups to evaluate the effectiveness of each method in reducing mortality and improving patient outcomes. Given the high mortality rates associated with abdominal sepsis, this research seeks to provide high-quality data to guide clinical decision-making in this critical area of care.

Who should consider this trial

Good fit: Ideal candidates for this study are patients undergoing surgery for severe intra-abdominal infections with evidence of contamination and septic shock.

Not a fit: Patients with conditions such as severe intra-abdominal hypertension or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates and better management strategies for patients suffering from abdominal sepsis.

How similar studies have performed: Previous studies have shown promising results with open abdomen management techniques, indicating potential for success in this approach.

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

Where this trial is running

Calgary, Alberta

• Foothills Medical Centre — Calgary, Alberta, Canada (RECRUITING)

Study contacts

• Principal investigator: Andrew W Kirkpatrick, MD — University of Calgary
• Study coordinator: Andrew Kirkpatrick, MD

Conditions: Abdominal Sepsis, Abdominal Infection, sepsis, abdominal infection, open abdomen management, Negative pressure peritoneal therapy