Closure After Total Shoulder Arthroplasty: Prineo vs Dermabond

Study Overview
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Brief Summary
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The objective is to compare two types of wound closure after total shoulder arthroplasty to determine which closure is faster, and subsequently if there are different outcomes between the two types of closures. The objective of this study is to compare two types of wound closure after total shoulder arthroplasty procedures. A single fellowship trained shoulder surgeon will perform all procedures. It is hypothesized that participants who undergo an 2-Octyl Cyanoacrylate (OCA) mesh closure will have a faster closure time, lower cost, non-inferior complication rate, and non-inferior satisfaction scores with respect postoperative follow up and scar appearance. Participants in the OCA mesh cohort will be compared to participants who have a closure with a running monocryl suture and dermabond. This investigation seeks to determine if OCA closure mesh closure is non-inferior to monocryl suture and dermabond in terms of operative time, cost, complications, and aesthetic appearance. If the hypothesis is confirmed, this study will suggest that a OCA mesh closure may be used for total shoulder arthroplasty surgeries as an alternative to current conventional closures and may provide a cost benefit.

Official Title
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Closure After Total Shoulder Arthroplasty: Subcuticular Closure With 2-Octyl Cyanoacrylate Versus 2-Octyl Cyanoacrylate With A Self-Adhering Mesh (Dermabond Prineo)

Conditions
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Shoulder Arthritis, Shoulder Arthropathy Associated With Other Conditions

Intervention / Treatment
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* Device: 2-Octyl Cyanoacrylate and Mesh
* Device: 2-Octyl Cyanoacrylate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Total shoulder arthroplasty Reverse total shoulder arthroplasty Age 18-100 Single Surgeon Exclusion Criteria: Previous shoulder surgery Known wound healing complications DM, chronic steroid use, vascular insufficiency, morbid obesity (BMI>40), ESRD, family hx of pathologic scars Patients on blood thinners (ASA 81mg ok) Connective tissue disease Allergy to skin adhesive Mentally unable to complete questionnaires Previous wound over planned incision

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: * Prospective Randomized Design o After determining a participant's eligibility for inclusion, participant will be randomized to the OCA mesh group or monocryl with dermabond group. After surgery, both groups will be seen at the 2 week, 6 week, and 3 month appointments
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2-Octyl Cyanoacrylate and mesh<br>The wound will be closed with 2-Octyl Cyanoacrylate and a mesh | Device: 2-Octyl Cyanoacrylate and Mesh<br>* 2-Octyl Cyanoacrylate and a mesh will be applied to final closure of wounds after undergoing a Total Shoulder Arthroplasty<br>* Other names: Prineo;|
| Active Comparator: 2-Octyl Cyanoacrylate<br>The wound will be closed with just 2-Octyl Cyanoacrylate | Device: 2-Octyl Cyanoacrylate<br>* Incisions will be closed with 2-Octyl Cyanoacrylate after undergoing a Total shoulder arthroplasty<br>* Other names: Dermabond;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for Incision Closure | A stopwatch will be used to measure the time it takes for the incision to be closed. When the surgical implants are in place and irrigation is complete, the surgeon will announce that he will start the closure and a nurse will start the stopwatch to measure how long it takes for the surgeon to close the incision. | During surgery (approximately 40 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of Closure | Cost of closure will be assessed by the cost of the time in the operating room and the cost of materials used to close the incision | Immediately post surgery | 
| Wound Appearance | The surgeon and participant will fill out the Patient and Observer Scar Assessment Scale (POSAS). This is a survey used to assess the participant and the surgeons opinion of the appearance of the wound. The Patient and Observer Scar Assessment Scale (POSAS) is a questionnaire that was developed to assess scar quality. It consists of two separate six-item scales (Observer Scale and Patient Scale), both of which are scored on a 10-point rating scale. Each questionnaire consists of 7 questions, each graded 1 through 10. The minimum score is 7 (most like normal skin) and the maximum score is 70 (very different from normal skin). The observer is the surgeon. The observer and patient scores can then be added together to determine the collective score. | At each follow up visit up to 3 months after surgery | 
| Dehiscence | The wound will be assessed for dehiscence (incision opening) which will be recorded as a yes or no. A dehiscence is defined as exposure of the underlying subcutaneous fat secondary to failure of the epidermal healing and may be accompanied by persistent wound drainage. It will be assessed by the length of the opening in centimeters and then normalized against the length of the entire incision. Furthermore, the number of wounds that open will be reported | At each follow up visit up to 3 months after surgery | 
| Wound Drainage | Dressing for each participant after surgery will be regulated and changed by the surgeon at the first post op visit. Drainage will be measured by outlining the drainage on gauze onto graph paper and measuring the area as previously validated in prior studies | At first post operative visit | 
| Superficial Infection | Number of wounds with superficial skin infections will be reported | At each follow up visit up to 3 months after surgery | 
| Deep Wound Infection | Number of deep wound infections found will be reported | At each follow up visit up to 3 months after surgery | 
| Number of Wounds That Require Post Operative Intervention | Will report the number of wounds that require post operative intervention | At each follow up visit up to 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prino, total shoulder arthroplasty, wound closure