Peritoneal Vacuum Therapy to Reduce Inflammatory Response From Abdominal Sepsis/Injury
NCT ID: NCT01355094
Last Updated: 2023-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2011-06-30
2022-06-30
Brief Summary
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The use or non-use of the open abdomen and its relationship to intra-abdominal hypertension (IAH) and the abdominal compartment syndrome (ACS), the level of IAH must be treated and if so how should be treated - remain controversial. The ultimate treatment for IAH/ACS is to leave the abdominal fascia open after laparotomy, utilizing some form of temporary abdominal closure (TAC) techniques, resulting in an "open abdomen"(OA). The decision to accept an OA can only be made in the operating room and is typically made quite arbitrarily (there is no current standard or protocol),and the TAC used is based on the surgeon's best judgment. The study intends to randomize patients after it has been decided that a TAC is required, which will be applied in the operating room while the patient is fully anesthetized. The only intervention required is to obtain small aliquots (a teaspoonful-15ml) of blood for the evaluation of inflammatory mediators levels, as well as the same volume of intra-peritoneal fluid-that is typically discarded in patients with OA.
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Detailed Description
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We propose a randomized trial of using either the "home Calgary Stampede Vac" involving wall suction or the KCI AbThera™ Abdominal Dressing, to dress the abdomen whenever the operative surgeon determines that an open abdomen is warranted to treat the patient.
In general, others have hypothesized that cytokines, especially peritoneal levels, are sensitive indicators of the post-operative inflammatory reaction and may predict complications. In experimental models IL-6 levels are higher in non-survivors. Further, previous work has noted that the blood level of IL-6, which has a longer half life than TNF-α or IL-1β, is a good index of the overall cytokine cascade activation. Thus the main outcomes to be compared will be between mean cytokine levels measured in each of the two treatment groups - to determine if the KCI AbThera™ Abdominal Dressing can significantly reduce the blood concentration of IL-6 when compared with the "Stampede VAC" system. We are hoping to better understand how the body responds to the inflammatory process that naturally occurs during and after an episode of intra-abdominal hypertension, to identify signals or markers of inflammation and infection as well as its progression and outcome.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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"Stampede" VAC
Calgary-home-made "Stampede" VAC system with only closed drain bulb suction
"Stampede" VAC
The time that the dressing will be left in place will be left to the discretion of the attending surgeon, but revised practice guidelines mandate either formal abdominal closure or dressing change at 24-96 hours from placement. Upon the first OA dressing change, the surgeon is free to utilize whatever temporary closure they choose.
Just prior to placement of the dressing, 16 ml (1 table spoon) of blood will be drawn from an existing arterial or venous line (this will qualify as Day 1). The same quantity of blood will be drawn on days 2, 3, 7 and 28 (or hospital discharge, whichever comes first). 15ml of peritoneal fluid will also be collected from the abdomen on the same days or until closure of the abdomen and removal of the dressing.
KCI AbThera
commercial AbThera vacuum assisted abdominal closure at 125 mmHg suction
KCI AbThera
The time that the dressing will be left in place will be left to the discretion of the attending surgeon, but revised practice guidelines mandate either formal abdominal closure or dressing change at 24-96 hours from placement. Upon the first OA dressing change, the surgeon is free to utilize whatever temporary closure they choose.
Just prior to placement of the dressing, 16 ml (1 table spoon) of blood will be drawn from an existing arterial or venous line (this will qualify as Day 1). The same quantity of blood will be drawn on days 2, 3, 7 and 28 (or hospital discharge, whichever comes first). 15ml of peritoneal fluid will also be collected from the abdomen on the same days or until closure of the abdomen and removal of the dressing.
Interventions
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KCI AbThera
The time that the dressing will be left in place will be left to the discretion of the attending surgeon, but revised practice guidelines mandate either formal abdominal closure or dressing change at 24-96 hours from placement. Upon the first OA dressing change, the surgeon is free to utilize whatever temporary closure they choose.
Just prior to placement of the dressing, 16 ml (1 table spoon) of blood will be drawn from an existing arterial or venous line (this will qualify as Day 1). The same quantity of blood will be drawn on days 2, 3, 7 and 28 (or hospital discharge, whichever comes first). 15ml of peritoneal fluid will also be collected from the abdomen on the same days or until closure of the abdomen and removal of the dressing.
"Stampede" VAC
The time that the dressing will be left in place will be left to the discretion of the attending surgeon, but revised practice guidelines mandate either formal abdominal closure or dressing change at 24-96 hours from placement. Upon the first OA dressing change, the surgeon is free to utilize whatever temporary closure they choose.
Just prior to placement of the dressing, 16 ml (1 table spoon) of blood will be drawn from an existing arterial or venous line (this will qualify as Day 1). The same quantity of blood will be drawn on days 2, 3, 7 and 28 (or hospital discharge, whichever comes first). 15ml of peritoneal fluid will also be collected from the abdomen on the same days or until closure of the abdomen and removal of the dressing.
Eligibility Criteria
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Inclusion Criteria
* Decision regarding the need to utilize an open abdomen technique after the first laparotomy
* Age \> 18
* Non-pregnant
Exclusion Criteria
* Patients receiving intra-peritoneal chemotherapy
* Pregnancy
* Age \< 18
18 Years
ALL
No
Sponsors
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3M
INDUSTRY
Alberta Health services
OTHER
University of Calgary
OTHER
Responsible Party
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Andrew W Kirkpatrick
Medical Director, Trauma Services, CD, MD, FACS, FRCSC, MHSc
Principal Investigators
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Andrew W Kirkpatrick, MD
Role: PRINCIPAL_INVESTIGATOR
Canadian Trauma Trials Collaborative
Locations
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Foothills Medical Centre
Calgary, Alberta, Canada
Countries
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References
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Other Identifiers
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E-23706
Identifier Type: -
Identifier Source: org_study_id
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