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Procedure

Closed vs. Open Abdomen Management for Sepsis

N/A

Recruiting

Led By Andrew W Kirkpatrick, MD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Septic shock

Be older than 18 years old

Must not have

Pancreatitis as the source of peritonitis

Uncontrolled bleeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours after participants enrolled in the study

Summary

This trial is designed to study which procedure is better: primarily closing the fascia after laparotomy for intra-abdominal infection (CLOSED), or leaving the fascia open and applying a temporary abdominal closure device (OPEN) with a vacuum drain.

Who is the study for?

This trial is for adults with severe abdominal sepsis, indicated by specific scores like the World-Society-of-Emergency-Surgery-Sepsis-Severity Score >8. It's not for pregnant individuals, those with high intra-abdominal pressure (IAP>20 mmHg), patients without plans for continued care, cases of pancreatitis-induced peritonitis, or uncontrolled bleeding.

What is being tested?

The study compares two methods to manage abdominal infections after surgery: 'Closed Abdomen Management' where the surgical cut is closed right away and 'Open Abdomen Management' where it's left open with a vacuum dressing applied. Participants are randomly assigned to one of these treatments.

What are the potential side effects?

Potential side effects may include complications from wound healing, infection risks due to an open abdomen, discomfort associated with dressings or drains used in treatment, and possible need for additional surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently experiencing septic shock.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My peritonitis is caused by pancreatitis.

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I do not have any ongoing issues with uncontrolled bleeding.

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I do not plan to continue receiving treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours after participants enrolled in the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours after participants enrolled in the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours after participants enrolled in the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The numbers of participants who are survival in hospital stay

Secondary study objectives

The days of intensive care unit stay

The pg/ml of blood Interleukin-6

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Open Abdomen Management with ANPPT dressingActive Control1 Intervention

The abdominal fascia will not be closed, but a temporally abdomenal closure (TAC) dressing (such as AbThera dressing) will be placed to protect the viscera with active Negative Pressure Peritoneal drain. Formal abdominal closure or dressing change at 24-72 hours from placement should be performed.

Group II: Closed Abdomen ManagementPlacebo Group1 Intervention

Primary closure of the abdominal fascia with placement of an intra-peritoneal drain (such as a Jackson-Pratt drain). Any decision to perform a re-laparotomy will be at the discretion of the treating surgical team.

0 / 4Eligibility criteria met