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

NCT ID: NCT00665730

Last Updated: 2015-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Abdominal Adhesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Sepraspray

Intervention Type DEVICE

Control

No anti-adhesion treatment used.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sepraspray

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

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Masarykova, , Czechia

Site Status

Prague, , Czechia

Site Status

Aarhus C, , Denmark

Site Status

Lille, , France

Site Status

Heidelberg, , Germany

Site Status

Cottingham, East Yorkshire, United Kingdom

Site Status

Countries

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Czechia Denmark France Germany United Kingdom

Other Identifiers

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SSPRAY00406

Identifier Type: -

Identifier Source: org_study_id

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