An Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery

Ulcerative Colitis Clinical Trial

Official title:

An Evaluation of the SprayShield Adhesion Barrier System in Reducing Post-Operative Adhesion in Abdominal Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01002287
• Other study ID #: ABD-08-001
• Status: Terminated
• Phase: N/A
• First received: October 26, 2009
• Last updated: November 7, 2014
• Start date: October 2009
• Est. completion date: May 2011

Study information

• Verified date: November 2014
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics CommitteePoland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This will be a prospective, multi-center, randomized, single blind study to collect and evaluate post-market clinical data on the SprayShield Adhesion Barrier System as an adjuvant to good surgical technique for the reduction of postoperative adhesion formation following major open abdominal surgery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: May 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of ulcerative colitis or familial polyposis and require two-stage surgery for treatment of either of these disorders will be eligible

Study Design

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

Related Conditions & MeSH terms

• Adenomatous Polyposis Coli
• Colitis, Ulcerative
• Familial Polyposis
• Ulcerative Colitis

Intervention

Device:
• SprayShield Adhesion Barrier System
Adhesion Barrier Device

Procedure:
• Good Surgical Technique Alone
Good Surgical Technique Alone

Locations

Country	Name	City	State
United States	Covidien	Bedford	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity.		10-12 Weeks post Initial Surgery for J-Pouch	No
Secondary	Severity of Adhesions	Worst midline adhesion severity score. The severity of adhesions was categorized as filmy thickness, avascular; moderate thickness, limited vascularity; and dense thickness, vascularised. The corresponding numeric severity ratings are "1", "2", and "3". Subjects without adhesions were assigned a severity rating of "0".	Average 10-12 weeks post surgery	No
Secondary	Adhesion Involvement Along the Midline Incision (Percentage)	The proportion of the total length of the initial midline incision associated with any adhesion at the time of the follow-up surgery, as determined by dividing the length of the incision associated with adhesions (cm) by the overall initial midline incision length (cm). This calculates the extent of adhesion involvement as a percentage.	average 10-12 weeks post surgery	No
Secondary	Mobilization Time	The time (minute) required to incise and mobilize the ileal loop in preparation for reanastomosis for ileostomy closure.	average 10-12 weeks post surgery	No