Closed Versus Open Abdomen in the Surgical Treatment of Severe Secondary Peritonitis: a Randomized Controlled Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Foothills Medical Centre
RECRUITING
Calgary
Contact Information
Primary
Andrew Kirkpatrick, MD
andrew.kirkpatrick@ahs.ca
403-944-2888
Time Frame
Start Date: 2019-06-02
Estimated Completion Date: 2025-12
Participants
Target number of participants: 550
Treatments
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.
Sponsors
Collaborators: Alberta Health services
Leads: University of Calgary

This content was sourced from clinicaltrials.gov

Similar Clinical Trials