Closure After Total Shoulder Arthroplasty: Prineo vs Dermabond

Montefiore Medicine Academic Health System

Status: Terminated

Conditions: Shoulder Arthropathy Associated With Other Conditions; Shoulder Arthritis

Treatments: Device: 2-Octyl Cyanoacrylate; Device: 2-Octyl Cyanoacrylate and Mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT03899753

2018-9370

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1 participants in 2 patient groups

2-Octyl Cyanoacrylate and mesh

Experimental group

Description:

The wound will be closed with 2-Octyl Cyanoacrylate and a mesh

Treatment:

Device: 2-Octyl Cyanoacrylate and Mesh

2-Octyl Cyanoacrylate

Active Comparator group

Description:

The wound will be closed with just 2-Octyl Cyanoacrylate

Treatment:

Device: 2-Octyl Cyanoacrylate