Abstract
BackgroundDamage 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/DesignThe 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.DiscussionResults 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 registrationClinicalTrials.gov identifier http://www.clicaltrials.gov/ct2/show/NCT01355094
Highlights
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 intraabdominal bleeding and contamination among critically ill or injured adults
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 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
In an attempt to limit this deranged physiology, damage control laparotomy, or abbreviated initial laparotomy followed by temporary abdominal closure (TAC) and planned re-operation after intensive care unit (ICU) resuscitation, is increasingly used to manage intra-abdominal bleeding and contamination among these patients [5,6,7,8,9,10]
Summary
Abbreviated initial laparotomy followed by temporary abdominal closure (TAC), intensive care unit resuscitation, and planned re-laparotomy, is frequently used to manage intraabdominal bleeding and contamination among critically ill or injured adults. Trauma affects approximately 700 million people, including 30 million North Americans and 2 million Canadians, worldwide each year [1,3] These injuries result in 5 million deaths, with blunt and penetrating abdominal trauma constituting a substantial proportion of trauma-related mortality [1,3,4]. In an attempt to limit this deranged physiology, damage control laparotomy, or abbreviated initial laparotomy followed by temporary abdominal closure (TAC) and planned re-operation after intensive care unit (ICU) resuscitation, is increasingly used to manage intra-abdominal bleeding and contamination among these patients [5,6,7,8,9,10]. The stages of damage control laparotomy broadly include: (1) limited initial operation with temporary control of hemorrhage and contamination; (2) application of a TAC device; (3) ICU resuscitation; and (4) re-operation with attempted completion of definitive surgical repairs after normalization of patient physiology [5,7,8,9]
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