Evaluation of the Safety of Sepraspray in Open Abdominal Surgery

Adhesion Prevention (Abdominal) Clinical Trial

Official title:

Evaluation of the Safety of Sepraspray in Open Abdominal Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00778479
• Other study ID #: SSPRAY00508
• Status: Terminated
• Phase: N/A
• First received: October 22, 2008
• Last updated: March 19, 2015
• Start date: October 2008
• Est. completion date: May 2009

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 155
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adhesion Prevention (Abdominal)

Intervention

Device:
• Sepraspray
Max. 10g of Sepraspray

Locations

Country	Name	City	State
France	Chu Hotel Dieu	Clamond
France	CHRU de Lille, Hopital Huriez	Lille
France	Hopital de la Croix Rousse	Lyon
France	Hopital Lariboisiere	Paris
Sweden	University Hospital	Linkoping
Sweden	Karolinska University Hospital	Stockholm
Sweden	Akademiska Sjukhuset	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

France,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity		30 days	No