A Trial to Assess the Effect and Safety of the C-Qur™ Film (CLIPEUS)
Adhesions develop in more than 90% of patients undergoing an intra-abdominal surgical leading to serious consequences and complications at reoperation.
The investigators initiate a prospective, randomized, controlled, multicenter trial to assess whether the use of C-Qur™ Film decreases the incidence of adhesion formation in subjects undergoing colorectal surgery. Treatment with the application of C-Qur™ Film as an adhesion prevention barrier for colorectal surgery will be compared with the control group at the second stage ostomy takedown procedure. The primary outcome evaluation will be assessment of adhesions to the incision site.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Randomized, Controlled, Clinical Trial to Assess the Effect and Safety of the C-Qur™ fiLm, an antI-adhesive Barrier for the PrevEntion of sUrgical adhesionS|
- adhesions at the incision site [ Time Frame: 8-16 weeks after index surgery ] [ Designated as safety issue: No ]The incidence of adhesions at the incision site
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
No Intervention: Control
No placement of an adhesion barrier
C-Qur film placement beneath the incision. Possibly placement of C-Qur film at other sites considered to be adhesiogenic (but not around the anastomosis)
In subjects assigned to the treatment arm, the C-Qur™ Film must be applied beneath the incision. The C-Qur™ film can also be applied to other areas considered to be adhesiogenic (e.g. the dissection site and ostomy site but not around the anastomosis). The number of C-Qur™ Film sheets placed is limited to a maximum area of coverage of 774cm2.
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|Contact: Martijn Stommel, MDemail@example.com|
|Contact: Chema Strik, MDfirstname.lastname@example.org|
|Department of Surgery, Radboud University Nijmegen Medical Center|
|Nijmegen, Netherlands, 6500 HB|
|Study Chair:||Harry van Goor, MD, PhD||Department of Surgery, Radboud University Nijmegen Medical Center|