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Study terminated due to low enrollment.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sepraspray | Experimental | 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. |
|
| Control | No Intervention | No anti-adhesion treatment used. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sepraspray | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision | 8-14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary: efficacy endpoints include the extent of adhesions to the midline incision and the severity of adhesions to the midline incision. | 8-14 weeks | |
| Safety: safety endpoints include assessments of adverse events, vital signs, incisional wound healing, clinical laboratory evaluations, and concomitant medications. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masarykova | Czechia | |||||
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| 8-14 weeks |
| Prague |
| Czechia |
| Aarhus C | Denmark |
| Lille | France |
| Heidelberg | Germany |
| Cottingham | East Yorkshire | United Kingdom |