Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients
Condition: Open Abdomen; Abdominal Adhesions; Trauma; Wounds and Injury
MeSH terms: Tissue Adhesions; Wounds and Injuries
Study type: Interventional

Summary: 
      The goal of this study is to test the effects of Seprafilm adhesion barrier on patients who
      are undergoing open abdomen damage control management for traumatic injuries when compared to
      no adhesion barrier use. Specifically, the researchers wish to study the effects of Seprafilm
      adhesion barrier on:

        -  the number and intensity of adhesions,

        -  whether there is any difference between treatment groups (Seprafilm vs. no Seprafilm)
           who go on to successful definitive abdominal closure,

        -  rate of occurrence of secondary complications (such as abscesses) associated with short-
           and long-term beneficial effects of reducing adhesion formation,and

        -  whether there is any difference between treatment groups regarding patient functional
           recovery.
    

Detailed description: 
      Data to be analyzed includes:

      Age, gender, traumatic injuries, trauma alert level, procedure information, length of
      hospital stay, length of ICU stay, interval between admission and initial operation, interval
      between operations, whether operation took place during the day or night, duration of
      operation in minutes, number of surgeons present during the operation, description of the
      initial operation, justification for using damage control approach, complications noted,
      injuries missed or delayed in diagnosis, Acute Physiology and Chronic Health Evaluation II
      (APACHE II) calculations at various time points, Simplified Acute Physiology Score (SAPS II)
      calculations at various time points, Glasgow Coma Score (GCS) calculations at various time
      points, changes in GCS at over time, Injury Severity Score (ISS) at various time points,
      Abbreviated Injury Scale (AIS) at various time points, Penetrating Abdominal Trauma Index
      score (if applicable) at various time points, complete blood count (CBC) results at various
      time points, blood chemistry results at various time points, blood gas results at various
      time points, subject randomization information, number of operations, adhesion scores (Zuhlke
      and Yaacobi) for each operative procedure, contamination score for each operative procedure,
      diagnosis and description of sub-procedures for each operative procedure, wound
      characteristics from the start and end of all operative procedures (e.g. length and width of
      the fascia and skin), type of abdominal coverage or closure, discharge destination (e.g.
      home, short term rehabilitation facility, etc.), Functional Outcome Measure score, Glasgow
      Outcome Score (GOS) at various time points, number and interval of post discharge follow-up
      visits, wound characteristics since discharge at several time points and
      complications/complaints noted since discharge at several time points.
    

Intervention name(s): Seprafilm
Intervention type(s): Biological
Intervention description(s): Two sheets of the Seprafilm material will be applied at each reoperation. Each sheet will be cut into 1x1 inch squares and applied to the following anatomic areas:
Two Seprafilm pieces between the liver and the anterior abdominal wall
Four pieces over the exposed bowel surfaces anteriorly
Two slightly staggered pieces of Seprafilm in each colic gutter
Two pieces in the pelvic area.
If any of the above areas involve an anastomosis or bowel repair, then the Seprafilm should be placed at least 1 inch away from the anastomosis and/or bowel repair.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Open Abdomen; Damage Control; Trauma; Wound healing; Gun shot wounds; Stab wounds; Automobile accidents; Wounds and Injury