COR-KNOT Versus Manually Hand-tied Knots

Study Overview
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Brief Summary
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The COR-KNOT technology (LSI SOLUTIONS, Victor, New York USA) was developed to replace suture tying with a faster procedure during surgery. While preclinical studies confirmed the speed of COR-KNOT use, no clinical studies have quantitatively compared the speed of suture fixation delivered by the COR-KNOT device with the speed of conventional hand-tied knots. COR-KNOT is expensive, costing 189 $ per application. Given this added expense, it is important to quantify the time-saved by application of this technology.

Detailed Description
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The COR-KNOT device was developed to make suture fixation faster and save operative time. With a single squeeze of the lever, the device remotely and automatically secures sutures with a titanium fastener, while also simultaneously trimming excess suture tails. This device has been accepted by cardiac surgeons for the recognized benefits of time savings, simplicity, and reliability. While the device presents ergonomic advantages during minimally invasive cardiac surgery, it enjoys widespread use in sternotomy-based, standard heart surgery. The relative cost of the device as a function of time saved has not been assessed. The purpose of this trial is to determine the relative time savings and cost of COR-KNOT compared to standard hand-tied knots in patients undergoing mitral/tricuspid ring annuloplasty repairs via traditional open heart surgery. Valve repair surgery is a common setting for COR-KNOT use and therefore serves as an appropriate procedure for evaluation of the technology. The investigators propose a prospective, randomized trial in patients undergoing mitral or tricuspid ring annuloplasty repair to 1) Determine the time require per knot for COR-KNOT versus standard hand-tied knots and 2) Quantify the relative cost of COR-KNOT versus that of standard, hand-tied knots. Data from this study will enable the investigators to determine the cost-benefit of using COR-KNOT technology in cardiac surgery.

Official Title
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COR-KNOT Versus Manually Hand-tied Knots

Conditions
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Suture Tying

Intervention / Treatment
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* Device: COR-KNOT
* Procedure: Standard Suture Tying


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for Valvular ring annuloplasty for mitral and/or tricuspid valve repair Age > 18 years Able and willing to give informed consent Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COR-KNOT<br>The COR-KNOT device was developed to make suture fixation faster and save operative time. With a single squeeze of the lever, the device remotely and automatically secures sutures with a titanium fastener, while also simultaneously trimming excess suture tails. | Device: COR-KNOT<br>* The COR-KNOT device was developed to make suture fixation faster and save operative time. With a single squeeze of the lever, the device remotely and automatically secures sutures with a titanium fastener, while also simultaneously trimming excess suture tails.<br>|
| Active Comparator: Standard Suture Tying<br>Standard Suture Tying | Procedure: Standard Suture Tying<br>* Standard Suture Tying<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (seconds) required to use COR-KNOT vs. Standard Suture Tying |  | 60 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost (US Dollar) of using COR-KNOT vs. Standard Suture Tying | Assess cost using manufacturer price quotes (US$) | 60 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Time, COR-KNOT, Standard, Cost