Evaluation of the Safety of Sepraspray in Open Abdominal Surgery

Genzyme

Status: Terminated

Conditions: Adhesion Prevention (Abdominal)

Treatments: Device: Sepraspray

Study type: Interventional

Funder types: Industry

Identifiers

NCT00778479

SSPRAY00508

Details and patient eligibility

About

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.

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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155 participants in 2 patient groups

Sepraspray

Experimental group

Description:

Receive Sepraspray

Treatment:

Device: Sepraspray

Control

No Intervention group

Description:

no treatment