← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours after participants enrolled in the study
Awards & highlights

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.Check my eligibility
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.See study design
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
Select...
I am currently experiencing septic shock.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The numbers of participants who are survival in hospital stay
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

Alberta Health servicesOTHER
156 Previous Clinical Trials
647,231 Total Patients Enrolled
1 Trials studying Sepsis
50 Patients Enrolled for Sepsis
University of CalgaryLead Sponsor
782 Previous Clinical Trials
845,339 Total Patients Enrolled
2 Trials studying Sepsis
196 Patients Enrolled for Sepsis
Andrew W Kirkpatrick, MDPrincipal InvestigatorUniversity of Calgary
2 Previous Clinical Trials
195 Total Patients Enrolled
1 Trials studying Sepsis
50 Patients Enrolled for Sepsis

Media Library

Closed Abdomen Management (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03163095 — N/A
Sepsis Research Study Groups: Open Abdomen Management with ANPPT dressing, Closed Abdomen Management
Sepsis Clinical Trial 2023: Closed Abdomen Management Highlights & Side Effects. Trial Name: NCT03163095 — N/A
Closed Abdomen Management (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03163095 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still any available positions for participants in this experiment?

"According to the clinicaltrials.gov entry, this experiment is still recruiting participants after its initial posting on June 2nd 2019 and latest update on January 24th 2022."

Answered by AI

What is the current size of participation in this medical experiment?

"Affirmative. According to the clinicaltrials.gov portal, this trial is currently in pursuit of participants. The initial posting was on June 2nd 2019 and it has been revised lastly on January 24th 2022 – with an ambition of finding 550 patients through 1 centre."

Answered by AI
Recent research and studies
~115 spots leftby Jul 2025