NCT00813397

Brief Summary

This study will examine the performance of SeprasSpray in patients undergoing abdominal surgery (laparoscopic).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

15 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

10 months

First QC Date

December 19, 2008

Last Update Submit

May 21, 2015

Conditions

Adhesion Prevention

Outcome Measures

Primary Outcomes (1)

  • Morbidity

    30 days

Study Arms (2)

Sepraspray

EXPERIMENTAL

Receive Sepraspray

Device: Sepraspray

Control

NO INTERVENTION

No Treatment, No Placebo

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 laparoscopic abdominal surgery

You may not qualify if:

  • Patients who are pregnant or have an ongoing infectious complications from a previous surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

CHU Amiens Nord

Amiens, 80054, France

Location

Hopital Avicenne

Bobingy, 93009, France

Location

Hopital Beaujon

Clichy, 92110, France

Location

Centre Hospitalier Simone Veil

Eaubonne, 95602, France

Location

Hopital Nord

Marseille, 13915, France

Location

CHR Nantes-Hopital Hotel Dieu

Nantes, 44093, France

Location

CHU Hopital de le'Archet

Nice, 06200, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

CHU Bordeaux-Hopital du Haut Leveque

Pessac, 33604, France

Location

CHU Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Hospitalier Intercommunal de Poissy Saint-German

Poissy, 78300, France

Location

CHU Charles Nicolle

Rouen, 76031, France

Location

CHU Bordeaux Saint Andre

Talence, 33404, France

Location

Hopital Purpan

Toulouse, 31509, France

Location

CHU Hopital Trousseau

Tours, 37044, France

Location

Related Publications (1)

  • Berdah SV, Mariette C, Denet C, Panis Y, Laurent C, Cotte E, Huten N, Le Peillet Feuillet E, Duron JJ. A multicentre, randomised, controlled trial to assess the safety, ease of use, and reliability of hyaluronic acid/carboxymethylcellulose powder adhesion barrier versus no barrier in colorectal laparoscopic surgery. Trials. 2014 Oct 27;15:413. doi: 10.1186/1745-6215-15-413.

    PMID: 25348087DERIVED

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

December 19, 2008

First Posted

December 23, 2008

Study Start

September 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations

FR(15)