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

Abdominal Adhesions Clinical Trial

Official title:

Evaluation of the Safety and Effectiveness of Sepraspray™ in Limiting the Formation of Postoperative Adhesions to Serosal Tissue (Abdominal Surgery)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00665730
• Other study ID #: SSPRAY00406
• Status: Terminated
• Phase: N/A
• First received: April 23, 2008
• Last updated: May 7, 2015
• Start date: July 2007
• Est. completion date: June 2008

Study information

• Verified date: May 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Denmark: Danish Medicines AgencyCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Abdominal Adhesions
• Tissue Adhesions

Intervention

Device:
• Sepraspray

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

Czech Republic,  Denmark,  France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision		8-14 weeks	No
Secondary	Secondary: efficacy endpoints include the extent of adhesions to the midline incision and the severity of adhesions to the midline incision.		8-14 weeks	No
Secondary	Safety: safety endpoints include assessments of adverse events, vital signs, incisional wound healing, clinical laboratory evaluations, and concomitant medications.		8-14 weeks	No