NCT00665730

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2007

Geographic Reach
5 countries

6 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

July 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

April 23, 2008

Last Update Submit

May 7, 2015

Conditions

Abdominal Adhesions

Outcome Measures

Primary Outcomes (1)

  • Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision

    8-14 weeks

Secondary Outcomes (2)

  • 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.

    8-14 weeks

Study Arms (2)

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.

Device: Sepraspray

Control

NO INTERVENTION

No anti-adhesion treatment used.

Interventions

SeprasprayDEVICE
Sepraspray

Eligibility Criteria

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

You may qualify if:

  • Patients who are scheduled to undergo a total proctocolectomy and a pelvic pouch with diverting ileostomy.

You may not qualify if:

  • Patients who are pregnant.
  • Patients with ongoing abdominal abscess.
  • Patients with ongoing bacterial peritonitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Masarykova, Czechia

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Aarhus C, Denmark

Location

Unknown Facility

Lille, France

Location

Unknown Facility

Heidelberg, Germany

Location

Unknown Facility

Cottingham, East Yorkshire, United Kingdom

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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 24, 2008

Study Start

July 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

May 8, 2015

Record last verified: 2015-05

Locations

DE(1)DK(1)FR(1)GB(1)CZ(2)