At a glance
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Seprafilm in Open Abdomens: a Prospective Evaluation of Wound and Adhesion Characteristics in Trauma Damage Control (OASIT)
In Brief
A clinical study evaluating Seprafilm for Open Abdomen and 3 related conditions. Completed, enrolled 30 participants across 5 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.