TerminatedNot Applicable

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

Stopped: Study terminated due to low enrollment.

Czechia, Denmark, France5 participantsStarted 2007-07

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

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

Timeframe: 8-14 weeks

Trial details

NCT IDNCT00665730

SponsorGenzyme, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-06

View on ClinicalTrials.gov More Abdominal Adhesions trials