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

study id #: NCT01002287

condition: Ulcerative Colitis, Familial Polyposis

status: terminated

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.

intervention:
Device: SprayShield Adhesion Barrier System Procedure: Good Surgical Technique Alone

start date: October 2009

estimated completion: May 2011

last updated: November 20, 2014

phase of development: Not Available

size / enrollment: 11

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

primary outcomes:

• 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 ] [ Designated as safety issue: No ]

secondary outcomes:

• Severity of Adhesions [ Time Frame: Average 10-12 weeks post surgery ] [ Designated as safety issue: No ]
  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) [ Time Frame: average 10-12 weeks post surgery ] [ Designated as safety issue: No ]
  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 [ Time Frame: average 10-12 weeks post surgery ] [ Designated as safety issue: No ] The time (minute) required to incise and mobilize the ileal loop in preparation for reanastomosis for ileostomy closure.

inclusion criteria:

exclusion criteria:

sponsor: Integra LifeSciences Corporation

trial center locations: United States