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

Genzyme, a Sanofi Company5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Abdominal Adhesions

Interventions

SeprasprayDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Unnamed facility

Masarykova, Czechia

Unnamed facility

Prague, Czechia

Unnamed facility

Aarhus C, Denmark

Unnamed facility

Lille, France

Unnamed facility

Heidelberg, Germany

Outcomes

Primary Outcomes

Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision

Time frame: 8-14 weeks

Secondary Outcomes

Secondary: efficacy endpoints include the extent of adhesions to the midline incision and the severity of adhesions to the midline incision.

Time frame: 8-14 weeks

Safety: safety endpoints include assessments of adverse events, vital signs, incisional wound healing, clinical laboratory evaluations, and concomitant medications.

Time frame: 8-14 weeks

Data from ClinicalTrials.gov

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