The Cohera Sylys® Surgical Sealant study is a prospective, randomized, controlled, multicenter clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) in patients undergoing a colectomy procedure with a stapled anastomosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
58
Standard Stapled Anastomosis Colectomy Procedure with the addition of Sylys® Surgical Sealant
Standard Stapled Anastomosis Colectomy Procedure without the addition of Sylys® Surgical Sealant
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Southern Alabama
Mobile, Alabama, United States
Safety of Sylys® Surgical Sealant: Number of Anastomosis-Related Complications
Number of subjects with anastomosis-related complications
Time frame: 26 Weeks
Sealant Application Evaluation Questionnaire
Questionnaire documenting the ability to apply the sealant adequately to the anastomosis
Time frame: At time of device application (during surgery)
Reduction in Anastomotic Leaks
Comparison of anastomotic leak rate across all subjects
Time frame: 26 Weeks
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University of California Irvine
Orange, California, United States
University of Colorado Denver
Denver, Colorado, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Tulane
New Orleans, Louisiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Stony Brook University Hospital
Stony Brook, New York, United States
...and 6 more locations