Clinical Evaluation of Cohera Sylys Surgical Sealant as an Adjunct to Standard Bowel Anastomosis Closure

Not Applicable

Completed

• Conditions: Stoma Reversal Procedure
• Interventions: Device: Sylys Surgical Sealant

• 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

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-07
• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-18
• Last Update Submitted: 2014-07-18
• Study First Posted: 2014-07-22
• Last Update Posted: 2014-07-22

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

Arm && Interventions

Group	Intervention	Description
Test	Sylys Surgical Sealant	All test arm subjects received Sylys Surgical sealant around anastomotic junction after closure.

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	30 days