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

May 7, 2015 updated by: Genzyme, a Sanofi Company

Evaluation of the Safety and Effectiveness of Sepraspray™ in Limiting the Formation of Postoperative Adhesions to Serosal Tissue (Abdominal Surgery)

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sepraspray
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.
Device: Sepraspray
No Intervention: Control
No anti-adhesion treatment used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision
Time Frame: 8-14 weeks
8-14 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
8-14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimate)

April 24, 2008

Study Record Updates

Last Update Posted (Estimate)

May 8, 2015

Last Update Submitted That Met QC Criteria

May 7, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSPRAY00406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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