Recruiting

Abdominal Sepsis

Sponsor:

University of Calgary

Code:

NCT03163095

Conditions

Abdominal Sepsis

Abdominal Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Open Abdomen Management with ANPPT dressing

Closed Abdomen Management

Study Details

Brief summary:

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.

Conditions

Abdominal Sepsis

Abdominal Infection

Study ID

NCT03163095

Start date

Jun 2, 2019

Status verified date

Feb, 2023

Completion date

Dec, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

550 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Open Abdomen Management with ANPPT dressing

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.

sham comparator: Closed Abdomen Management

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.

Interventions

Open Abdomen Management with ANPPT dressing

The abdominal fascia will not be closed, but a temporally abdominal closure (TAC) dressing, such as AbThera dressing, will be placed to protect the viscera with active Negative Pressure Peritoneal Therapy.

The time that the TAC dressing will be changed will be left to the discretion of the attending surgeon, but practice guidelines mandate either formal abdominal closure or dressing change at 24-72 hours from placement.

Blood samples and peritoneal fluid will be drawn up to 72 hours after enrollment.

Closed Abdomen Management

Primary closure of the abdominal fascia with placement of an intra-peritoneal drain (such as a Jackson-Pratt drain).

This strategy will allow drainage of intra-peritoneal fluid for both clinical reasons and to facilitate intra-peritoneal fluid testing. Closure or not of the skin will be left to the attending surgeons discretion. Any decision to perform a relaparotomy (Relaparotomy on Demand) will be at the discretion of the treating critical care teams, and in no way mandated by this recruitment.

Blood samples and peritoneal fluid (if available) will be drawn up to 72 hours after enrollment.

Primary outcome measure

  • The numbers of participants who are survival in hospital stay [ Time Frame: 90 days after participants enrolled in the study ]

Central Contacts and Locations

Central contacts

Andrew Kirkpatrick, MD

403-944-2888andrew.kirkpatrick@ahs.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Andrew W Kirkpatrick, MD

403-944-2888andrew.kirkpatrick@albertahealthservices.ca

Jimmy Xiao, MD, PhD

403-944-8750jimmy.xiao@albertahealthservices.ca

Principal Investigator:

Andrew W Kirkpatrick, MD

More Information

Sponsor

University of Calgary

Last update posted

Feb 3, 2023

Last verified

Feb, 2023

Keywords

  • sepsis
  • abdominal infection
  • open abdomen management
  • Negative pressure peritoneal therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2023-02-03.