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Closed or Open Abdomen for the Management of Abdominal Sepsis

NCT03163095 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2023-02-03

No results posted yet for this study

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

Interventions

DEVICE

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.

OTHER

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.

Sponsors & Collaborators

  • Alberta Health services

    collaborator OTHER

  • University of Calgary

    lead OTHER

Principal Investigators

  • Andrew W Kirkpatrick, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-02
Primary Completion
2025-07-31
Completion
2025-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03163095 on ClinicalTrials.gov