Adhesion Prevention (Abdominal) Clinical Trial
Official title:
Evaluation of the Safety of Sepraspray in Open Abdominal Surgery
This study will examine the Performance of Sepraspray in Patients undergoing open abdominal
surgery
NOTE regarding reason for study termination:
A patient death reported during the trial warranted temporary suspension for review by the
independent data review committee. Although the committee recommended continuing enrollment,
enrollment was electively terminated by the sponsor.
A preliminary analysis did not identify any new risk that was not listed on the
investigational labeling for this product. A full analysis of the results is expected to
allow characterization of the risk/benefit and clinical utility of the product in the
exposed patient population.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment