Trauma Clinical Trial
Official title:
Seprafilm in Open Abdomens: a Prospective Evaluation of Wound and Adhesion Characteristics in Trauma Damage Control (OASIT)
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.
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.
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