NCT00778479

Brief Summary

This study will examine the Performance of Sepraspray in Patients undergoing open abdominal surgery NOTE regarding reason for study termination: A patient death reported during the trial warranted temporary suspension for review by the independent data review committee. Although the committee recommended continuing enrollment, enrollment was electively terminated by the sponsor. A preliminary analysis did not identify any new risk that was not listed on the investigational labeling for this product. A full analysis of the results is expected to allow characterization of the risk/benefit and clinical utility of the product in the exposed patient population.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Shorter than P25 for not_applicable

Geographic Reach
2 countries

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

October 22, 2008

Last Update Submit

March 19, 2015

Conditions

Adhesion Prevention (Abdominal)

Outcome Measures

Primary Outcomes (1)

  • Morbidity

    30 days

Study Arms (2)

Sepraspray

EXPERIMENTAL

Receive Sepraspray

Device: Sepraspray

Control

NO INTERVENTION

no treatment

Interventions

SeprasprayDEVICE

Max. 10g of Sepraspray

Sepraspray

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years old and over that require open abdominal surgery

You may not qualify if:

  • Patients who are pregnant or have ongoing abdominal abscess or bacterial peritonitis or have infectious complications from a previous laparectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Chu Hotel Dieu

Clamond, France

Location

CHRU de Lille, Hopital Huriez

Lille, France

Location

Hopital de la Croix Rousse

Lyon, France

Location

Hopital Lariboisiere

Paris, France

Location

University Hospital

Linköping, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Akademiska Sjukhuset

Uppsala, Sweden

Location

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 23, 2008

Study Start

October 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

FR(4)SE(3)