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Closed or Open Abdomen for the Management of Abdominal Sepsis

Abdominal Sepsis | Abdominal Infection

This is a prospective randomized clinical study. The study will comprise the randomized decision to either A) primarily close the fascia after laparotomy for intra-abdominal infection (CLOSED); or B) leave the fascia open after laparotomy and apply a temporary abdominal closure (TAC) device (OPEN) with a vacuum drain.

Although debatable, both procedures (CLOSED or OPEN abdomen) are acceptable based on current suggested standard of care. Thus, high quality data to direct clinical decision making in this highly lethal condition is urgently required.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation 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

Study Location

Foothills Medical Centre
Foothills Medical Centre
Calgary, Alberta
Canada

Contact Study Team

Backup Contact

Jimmy Xiao, MD, PhD

[email protected]
403-944-8750
Primary Contact

Andrew W Kirkpatrick, MD

[email protected]
403-944-2888
Study Sponsored By
University of Calgary
Participants Required
More Information
Study ID: NCT03163095