Open Access Study protocol

Efficacy and safety of active negative pressure peritoneal therapy for reducing the systemic inflammatory response after damage control laparotomy (the Intra-peritoneal Vacuum Trial): study protocol for a randomized controlled trial

Derek J Roberts12, Craig N Jenne38, Chad G Ball145, Corina Tiruta5, Caroline Léger38, Zhengwen Xiao5, Peter D Faris26, Paul B McBeth9, Christopher J Doig23, Christine R Skinner3, Stacy G Ruddell3, Paul Kubes378 and Andrew W Kirkpatrick135*

Author Affiliations

1 Department of Surgery, University of Calgary and the Foothills Medical Centre, North Tower 10th Floor, 1403-29th Street Northwest, Calgary, Alberta, T2N 2T9, Canada

2 Department of Community Health Sciences (Divisions of Epidemiology and Biostatistics), University of Calgary, TRW (Teaching, Research, and Wellness) Building, 3rd Floor, 3280 Hospital Drive Northwest, Calgary, Alberta, T2N 4Z6, Canada

3 Department of Critical Care Medicine, University of Calgary and the Foothills Medical Centre, Ground Floor McCaig Tower, 3134 Hospital Drive Northwest, Calgary, Alberta, T2N 5A1, Canada

4 Department of Oncology, University of Calgary and the Foothills Medical Centre, 1403-29th Street Northwest, Calgary, Alberta, T2N 2T9, Canada

5 Regional Trauma Program, University of Calgary and the Foothills Medical Centre, 1403-29th Street Northwest, Calgary, Alberta, T2N 2T9, Canada

6 Alberta Health Services – Research Excellence Support Team, University of Calgary and the Foothills Medical Centre, South Tower, 1403-29th Street Northwest, Calgary, Alberta, T2N 2T9, Canada

7 Hotchkiss Brain Institute, University of Calgary and the Foothills Medical Centre, Health Research Innovation Centre, 3330 Hospital Drive Northwest, Calgary, Alberta, T2N 4N1, Canada

8 Calvin, Phoebe and Joan Snyder Institute for Chronic Diseases, University of Calgary and the Foothills Medical Centre, Health Research Innovation Centre, 3280 Hospital Drive Northwest, Calgary, Alberta, T2N 4N1, Canada

9 Division of Critical Care Medicine, Department of Medicine, University of British Columbia and St. Paul’s Hospital, 1081 Burrard Street, Vancouver, British Columbia, V6Z 1Y6, Canada

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Trials 2013, 14:141  doi:10.1186/1745-6215-14-141

Published: 16 May 2013

Abstract

Background

Damage control laparotomy, or abbreviated initial laparotomy followed by temporary abdominal closure (TAC), intensive care unit resuscitation, and planned re-laparotomy, is frequently used to manage intra-abdominal bleeding and contamination among critically ill or injured adults. Animal data suggest that TAC techniques that employ negative pressure to the peritoneal cavity may reduce the systemic inflammatory response and associated organ injury. The primary objective of this study is to determine if use of a TAC dressing that affords active negative pressure peritoneal therapy, the ABThera Open Abdomen Negative Pressure Therapy System, reduces the extent of the systemic inflammatory response after damage control laparotomy for intra-abdominal sepsis or injury as compared to a commonly used TAC method that provides potentially less efficient peritoneal negative pressure, the Barker’s vacuum pack.

Methods/Design

The Intra-peritoneal Vacuum Trial will be a single-center, randomized controlled trial. Adults will be intraoperatively allocated to TAC with either the ABThera or Barker’s vacuum pack after the decision has been made by the attending surgeon to perform a damage control laparotomy. The study will use variable block size randomization. On study days 1, 2, 3, 7, and 28, blood will be collected. Whenever possible, peritoneal fluid will also be collected at these time points from the patient’s abdomen or TAC device. Luminex technology will be used to quantify the concentrations of 65 mediators relevant to the inflammatory response in peritoneal fluid and plasma. The primary endpoint is the difference in the plasma concentration of the pro-inflammatory cytokine IL-6 at 24 and 48 h after TAC dressing application. Secondary endpoints include the differential effects of these dressings on the systemic concentration of other pro-inflammatory cytokines, collective peritoneal and systemic inflammatory mediator profiles, postoperative fluid balance, intra-abdominal pressure, and several patient-important outcomes, including organ dysfunction measures and mortality.

Discussion

Results from this study will improve understanding of the effect of active negative pressure peritoneal therapy after damage control laparotomy on the inflammatory response. It will also gather necessary pilot information needed to inform design of a multicenter trial comparing clinical outcomes among patients randomized to TAC with the ABThera versus Barker’s vacuum pack.

Trial registration

ClinicalTrials.gov identifier http://www.clicaltrials.gov/ct2/show/NCT01355094 webcite

Keywords:
Abdominal injuries; Damage control laparotomy; Inflammation; Negative pressure wound therapy; Randomized controlled trial; Sepsis; Temporary abdominal closure; Wounds and injuries