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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ulcerative Colitis, Familial Polyposis

Intervention / Treatment
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* Device: SprayShield Adhesion Barrier System
* Procedure: Good Surgical Technique Alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of ulcerative colitis or familial polyposis and require two-stage surgery for treatment of either of these disorders will be eligible

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SprayShield Adhesion Barrier<br>SprayShield Adhesion Barrier | Device: SprayShield Adhesion Barrier System<br>* Adhesion Barrier Device<br>|
| Sham Comparator: Control<br>Good Surgical Technique Alone | Procedure: Good Surgical Technique Alone<br>* Good Surgical Technique Alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |