NCT03860181

Dermabond PRINEO for Total Shoulder Arthroplasty

Investigation of a New Skin Closure Device, Dermabond PRINEO, for Total Shoulder Arthroplasty: A Randomized, Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a research study to find out whether wound closure (the process of closing the surgical wound after the procedure is complete) with Dermabond PRINEO Skin Closure System (PRINEO) will be faster and improve wound healing compared to standard closing methods after total shoulder replacement. The PRINEO system involves using running stitches to close the wound, and then taping over the sutures with a sticky film that holds the wound closed.

Conditions

• Surgical Wound
• Shoulder Arthritis
• Surgical Incision

Interventions

Type	Name	Description
PROCEDURE	Subcuticular Sutures - Surgeon 1	This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
PROCEDURE	Metal Staples - Surgeon 2	This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
DEVICE	PRINEO - Surgeon 1	The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
DEVICE	PRINEO - Surgeon 2	The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.

Timeline

• Start date: 2019-03-25
• Primary completion: 2020-06-23
• Completion: 2020-06-23
• First posted: 2019-03-01
• Last updated: 2021-10-01
• Results posted: 2021-08-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study