Closed or Open Abdomen for the Management of Abdominal Sepsis
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|ClinicalTrials.gov Identifier: NCT03163095|
Recruitment Status : Not yet recruiting
First Posted : May 22, 2017
Last Update Posted : April 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Sepsis Abdominal Infection||Device: Open Abdomen Management with ANPPT dressing Other: Closed Abdomen Management||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||550 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomization by blocks on a website.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Research members in the laboratory will be blinded with participants' clinical data.|
|Official Title:||Closed Versus Open Abdomen in the Surgical Treatment of Severe Secondary Peritonitis: a Randomized Controlled Clinical Trial|
|Estimated Study Start Date :||June 2018|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||December 2022|
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.
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.
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.
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.
- The numbers of participants who are survival in hospital stay [ Time Frame: 90 days after participants enrolled in the study ]The rate of survival of participants in both arms
- The days of intensive care unit stay [ Time Frame: 30 days after participants enrolled in the study ]The median length of days in ICU needed by participants in both arms
- The pg/ml of blood Interleukin-6 [ Time Frame: 72 hours after participants enrolled in the study ]The mean concentrations of blood IL-6 in participants in both arms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163095
|Contact: Andrew Kirkpatrick, MDfirstname.lastname@example.org|
|Foothills Medical Centre|
|Calgary, Alberta, Canada, T2N 2T9|
|Principal Investigator:||Andrew W Kirkpatrick, MD||University of Calgary|