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Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery

NCT00130715 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-03-12

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy of Seprafilm in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs) associated with the use of Seprafilm occurring within 30 days postoperatively, and the incidence of abdominopelvic abscess within 6 months postoperatively.

Conditions

  • Intestinal Obstruction
  • Digestive System Surgical Procedures

Interventions

DEVICE

Seprafilm Bioresorbable Membrane

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-06-30
Completion
2003-08-31

Countries

  • United States
  • Canada
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00130715 on ClinicalTrials.gov