A Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Technique Plus Sylys® Surgical Sealant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-13

Study Completion Date

2018-05-31

Brief Summary

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The Cohera Sylys® Surgical Sealant study is a pivotal, prospective, randomized, controlled, multicenter superiority clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) during stapled colorectal and ileorectal anastomosis procedures.

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Detailed Description

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Conditions

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Colorectal and Ileorectal Anastomosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Test- Treatment with Sylys Surgical Sealant

Standard closure plus treatment with Sylys Surgical Sealant

Group Type EXPERIMENTAL

Test- Treatment with Sylys Surgical Sealan

Intervention Type DEVICE

Standard closure of stapled anastomosis plus treatment with Sylys Surgical Sealant

Control- Standard of Care

Control group is standard closure of anastomosis.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Test- Treatment with Sylys Surgical Sealan

Standard closure of stapled anastomosis plus treatment with Sylys Surgical Sealant

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Be at least 22 years of age
* Be scheduled for a stapled colorectal or ileorectal anastomosis procedure with or without diverting stoma
* Agree to return for all follow-up evaluations and procedures specified in the protocol
* Understand and give informed consent

Exclusion Criteria

* Albumin \< 3
* ASA ≥ 4
* Neutropenia ≤ 800
* Pregnancy
* The following conditions involving compromised immune system: AIDS (HIV positive not excluded), neutropenia
* Known blood clotting disorder requiring treatment
* Any condition known to effect wound healing, such as collagen vascular disease
* Have known or suspected allergy or sensitivity to any test materials or reagents
* Concurrent use of fibrin sealants or other anastomosis care devices
* Surgery for emergency abdominal indications
* Has undergone a colorectal anastomosis procedure in the previous two months
* Has an emergent infection related to a previous colorectal anastomosis procedure
* Is scheduled to undergo a Hartmann's procedure
* Is scheduled to undergo trans-anal endoscopic microsurgery (TEM) Is participating in another medical device trial related to colorectal anastomosis

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No