Evaluation of the Safety and Effectiveness of Sepraspray™ in Reducing Post-surgical Adhesions

Genzyme

Status: Terminated

Conditions: Abdominal Adhesions

Treatments: Device: Sepraspray

Study type: Interventional

Funder types: Industry

Identifiers

NCT00665730

SSPRAY00406

Details and patient eligibility

About

This study will examine the safety and efficacy of Sepraspray in the following model of abdominal surgery: total proctocolectomy and pelvic pouch with diverting ileostomy via laparotomy to treat ulcerative colitis or familial polyposis. Adhesion formation will be evaluated laparoscopically at ileostomy take down. NOTE: A decision was made to terminate this study in June 2008 due to low enrollment.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are scheduled to undergo a total proctocolectomy and a pelvic pouch with diverting ileostomy.

Exclusion criteria

• Patients who are pregnant.
• Patients with ongoing abdominal abscess.
• Patients with ongoing bacterial peritonitis.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5 participants in 2 patient groups

Sepraspray

Experimental group

Description:

Sepraspray Powder applied on the viscera directly under the midline incision followed by incision closure. Sepraspray dose applied was between 2 g and 4 g per patient.

Treatment:

Device: Sepraspray

Control

No Intervention group

Description:

No anti-adhesion treatment used.