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

Not Applicable

Terminated

• Conditions: Ulcerative Colitis; Familial Polyposis
• Interventions: Device: SprayShield Adhesion Barrier System; Procedure: Good Surgical Technique Alone

• Registration Number: NCT01002287
• Lead Sponsor: Integra LifeSciences Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-26
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-27
• Primary Completion: 2010-10
• Study Completion: 2011-05
• Results First Submitted: 2012-06-21
• Results First Submitted QC: 2013-12-23
• Results First Posted: 2014-01-29
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-07
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SprayShield Adhesion Barrier	SprayShield Adhesion Barrier System	SprayShield Adhesion Barrier
Control	Good Surgical Technique Alone	Good Surgical Technique Alone

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Severity of Adhesions	Average 10-12 weeks post surgery	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".
Adhesion Involvement Along the Midline Incision (Percentage)	average 10-12 weeks post surgery	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.
Mobilization Time	average 10-12 weeks post surgery	The time (minute) required to incise and mobilize the ileal loop in preparation for reanastomosis for ileostomy closure.

Trial Locations

Locations (1)

Covidien; 🇺🇸 Bedford, Massachusetts, United States