Evaluation of the Safety of Sepraspray in Open Abdominal Surgery

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.

Inclusion Criteria:

• Patients 18 years old and over that require open abdominal surgery

Exclusion Criteria:

• Patients who are pregnant or have ongoing abdominal abscess or bacterial peritonitis or have infectious complications from a previous laparectomy