Clinical Evaluation of Cohera Sylys Surgical Sealant as an Adjunct to Standard Bowel Anastomosis Closure
Not Applicable
Completed
- Conditions
- Stoma Reversal Procedure
- Registration Number
- NCT02196519
- Lead Sponsor
- Cohera Medical, Inc.
- Brief Summary
A first in human study evaluating the safety of Sylys Surgical Sealant in protecting the anastomotic junction created during a stoma reversal procedure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- Be at least 18 years of age
- Be in good general health in the opinion of the investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications
- Be scheduled for an ileostomy reversal procedure
- Be willing to follow instructions for incision care
- Agree to return for all follow-up evaluations specified in this protocol
- Sign informed consent
Exclusion Criteria
- Anesthesia risk judged to be higher than ASA2
- Have severe co-morbid conditions that pose a high risk for surgery and adequate recovery (e.g., heart disease)
- Any condition involving compromised immune system
- Any condition known to effect wound healing, such as collagen vascular disease
- Known blood clotting disorder
- Be receiving antibiotic therapy for pre-existing condition or infection
- Concurrent use of fibrin sealants or other anastomosis care devices
- Be currently taking systemic steroids or immunosuppressive agents
- Have known or suspected allergy or sensitivity to any test materials or reagents
- Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrollment in this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of Adverse Events 30 days
- Secondary Outcome Measures
Name Time Method