An Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery
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|ClinicalTrials.gov Identifier: NCT01002287|
Recruitment Status : Terminated (Study was terminated for business purposes, not for safety or efficacy reasons.)
First Posted : October 27, 2009
Results First Posted : January 29, 2014
Last Update Posted : November 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis Familial Polyposis||Device: SprayShield Adhesion Barrier System Procedure: Good Surgical Technique Alone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||An Evaluation of the SprayShield Adhesion Barrier System in Reducing Post-Operative Adhesion in Abdominal Surgery|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||May 2011|
Experimental: SprayShield Adhesion Barrier
SprayShield Adhesion Barrier
Device: SprayShield Adhesion Barrier System
Adhesion Barrier Device
Sham Comparator: Control
Good Surgical Technique Alone
Procedure: Good Surgical Technique Alone
Good Surgical Technique Alone
- 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: average 10-12 weeks post surgery ]The time (minute) required to incise and mobilize the ileal loop in preparation for reanastomosis for ileostomy closure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002287
|United States, Massachusetts|
|Bedford, Massachusetts, United States, 01710|