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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
11
Adhesion Barrier Device
Good Surgical Technique Alone
Covidien
Bedford, Massachusetts, United States
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.
Time frame: 10-12 Weeks post Initial Surgery for J-Pouch
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".
Time frame: 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.
Time frame: 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.
Time frame: average 10-12 weeks post surgery
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