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A Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant
A Prospective, Randomized, Controlled, Multicenter Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant
1 other identifier
interventional
58
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
Typical duration for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 18, 2016
CompletedFirst Posted
Study publicly available on registry
July 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2018
CompletedAugust 16, 2018
August 1, 2018
2.1 years
July 18, 2016
August 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Safety of Sylys® Surgical Sealant: Number of Anastomosis-Related Complications
Number of subjects with anastomosis-related complications
26 Weeks
Secondary Outcomes (2)
Sealant Application Evaluation Questionnaire
At time of device application (during surgery)
Reduction in Anastomotic Leaks
26 Weeks
Study Arms (2)
Test
EXPERIMENTALTest group will receive Sylys® Surgical Sealant as an adjunct to standard closure of stapled anastomosis in colectomy procedure.
Control
ACTIVE COMPARATORControl group will receive standard of care closure of stapled anastomosis in colectomy procedure without Sylys® Surgical Sealant.
Interventions
Standard Stapled Anastomosis Colectomy Procedure with the addition of Sylys® Surgical Sealant
Standard Stapled Anastomosis Colectomy Procedure without the addition of Sylys® Surgical Sealant
Eligibility Criteria
You may qualify if:
- Be 22 years of age or older
- Be scheduled for a colectomy procedure with a stapled anastomosis
- At time of surgery, has a completed anastomosis that is able to be visualized and is accessible to allow for circumferential sealant application with minimal bowel manipulation (≥90%)
- Completed anastomosis must be at a location where a WCE can be performed to evaluate for a sub-clinical leak
- Agree to return for all follow-up evaluations and procedures specified in the protocol
- Understand and give informed consent
You may not qualify if:
- Albumin \< 3 g/dL
- ASA score (American Society of Anesthesiologists) ≥ 4
- Neutropenia ≤ 800 cells/µl
- Pregnant at time of surgery
- Has AIDS (HIV positive not excluded)
- Has neutropenia (IBD and steroid use not excluded)
- Has a known blood clotting disorder requiring treatment
- Has any condition known to effect wound healing, such as collagen vascular disease
- Has known or suspected allergy or sensitivity to any test materials, reagents, or WCE contrast materials
- Has undergone chemotherapy within 4 weeks of the anastomosis procedure and/or radiation within 3 days of the anastomosis procedure
- Concurrently using fibrin sealants or other anastomosis care devices
- Emergency surgery for abdominal indications
- Has undergone a colectomy procedure in the previous two months
- Has an emergent infection related to a previous colectomy procedure
- Is scheduled to undergo a Hartmann's procedure
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Southern Alabama
Mobile, Alabama, 36617, United States
University of California Irvine
Orange, California, 92868, United States
University of Colorado Denver
Denver, Colorado, 80204, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
University of South Florida
Tampa, Florida, 33606, United States
Tulane
New Orleans, Louisiana, 70112, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Duke University
Durham, North Carolina, 27710, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Baylor Scott & White Research Institute
Dallas, Texas, 75246, United States
Houston Methodist
Houston, Texas, 77030, United States
Intermountain Healthcare
Ogden, Utah, 84403, United States
Univeristy of Utah
Salt Lake City, Utah, 84132, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2016
First Posted
July 22, 2016
Study Start
July 1, 2016
Primary Completion
August 13, 2018
Study Completion
August 13, 2018
Last Updated
August 16, 2018
Record last verified: 2018-08