NCT03899753

Closure After Total Shoulder Arthroplasty: Prineo vs Dermabond

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Shoulder Arthritis
• Shoulder Arthropathy Associated With Other Conditions

Interventions

Type	Name	Description
DEVICE	2-Octyl Cyanoacrylate and Mesh	2-Octyl Cyanoacrylate and a mesh will be applied to final closure of wounds after undergoing a Total Shoulder Arthroplasty
DEVICE	2-Octyl Cyanoacrylate	Incisions will be closed with 2-Octyl Cyanoacrylate after undergoing a Total shoulder arthroplasty

Timeline

• Start date: 2020-12-31
• Primary completion: 2021-04-21
• Completion: 2021-04-21
• First posted: 2019-04-02
• Last updated: 2023-07-03
• Results posted: 2023-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study