An Analysis of Cytokine Concentration in Open Abdominal Closure of Trauma Patients
Condition: Abdominal Trauma
MeSH terms: Wounds and Injuries; Abdominal Injuries
Study type: Observational

Summary: 
      The purpose of this study is to compare the pro-inflammatory and anti-inflammatory cytokines,
      protein content, and white blood cell (WBC) count present in the peritoneal fluid and plasma
      of trauma patients who undergo one of two different methods of open abdominal closure.
      Following analysis of the peritoneal fluid and serum samples, comparison of the results
      between the two groups will be completed and correlated with the overall organ function.
    

Detailed description: 
      Elevated pro and anti-inflammatory cytokines have been implicated as markers for multi-system
      organ failure (MOF) and death in trauma patients. Abdominal surgery can raise the levels of
      these cytokines and may lead to elevated plasma levels of these inflammatory cytokines
      possibly leading to worsening patient prognosis. Patients in whom open abdominal closure is
      required are often the sickest of trauma patients. Two different temporary abdominal closure
      techniques are generally used at the Presley Memorial Trauma Center, one using the blue
      towel: vacuum pack technique and one using the commercially available ABThera vacuum device
      from Kinetic Concepts, Inc (KCI). This study is being conducted to determine if the ABThera
      temporary closure technique removes a greater amount of cytokines from the abdominal cavity
      possibly lessening the amount of systemic or plasma cytokines and thus decreasing the
      incidence of MOF and death in this very ill population of patients. Additionally, this study
      is being conducted to determine if the white blood cell count may be lower in patients with
      the least cytokine values and to also investigate protein loss in these patients. The
      depletion of body stores of protein due to an open abdomen has great nutritional and,
      therefore, healing implications.

      Enrollment will include 40 subjects meeting eligibility criteria into this study. The study
      population will include 20 patients who were temporarily closed using the ABThera device and
      20 who were temporarily closed using the blue towel: vacuum pack technique. Peritoneal fluid
      and blood will be collected in eligible subjects immediately upon arrival to the ICU
      following surgery and at 12, 24, 48 and 72 hours following placement. Peritoneal fluid will
      be collected from the drainage system into a Lukens trap. Blood will be collected from an
      existing intravenous or arterial line. The peritoneal fluid will be centrifuged, separated,
      and frozen at -80 degrees centigrade for analysis of cytokine/inflammatory markers, protein,
      and WBC count. The blood specimens will be centrifuged, separated, and frozen for
      cytokine/inflammatory marker analysis. Chemistry and hematology values completed as standard
      of care will be collected from the hospital chart along with general demographics,
      description of injuries, treatment modalities, and outcomes.

      The first samples of blood and peritoneal fluid will be obtained immediately on arrival in
      the ICU when other labs are being drawn as standard of care. These samples will be put aside
      until consent can be obtained from the legally authorized representative or the subject
      himself. If the research subject and/or his legally authorized representative decide that the
      subject should not participate in the study, the sample will be destroyed and no additional
      study procedures will be obtained. If the legally authorized representative is not available
      within 12 hours of the initial specimen and the subject is unable to consider participation
      within 12 hours of the initial specimens, the subject will not be enrolled into the study,
      and samples obtained immediately on arrival to the ICU will be destroyed.

      After all analyses are completed, comparison of the cytokine levels, WBC count, and protein
      extraction between the two vacuum methods will be completed and correlated to the patients'
      overall organ function.
    

Intervention name(s): ABThera vacuum device; Blue towel: vacuum pack device
Intervention type(s): Device; Device
Intervention description(s): This intervention uses a commercially available vacuum device to temporarily close the abdomen following surgery.; This intervention uses operating room towels and the application of suction to temporarily close the abdomen following surgery.
Other intervention name(s): Commercially available vacuum pack closure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients admitted to the Presley Memorial Trauma Center undergoing open abdominal closure
        with a vacuum device will be invited to participate. A total of 40 patients with 20
        patients in each group will be included.
      
Biospecimen description: 
      peritoneal fluid and blood samples