Dermabond PRINEO for Total Shoulder Arthroplasty

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Shoulder Arthritis; Surgical Wound; Surgical Incision

Treatments: Device: PRINEO - Surgeon 1; Procedure: Metal Staples - Surgeon 2; Device: PRINEO - Surgeon 2; Procedure: Subcuticular Sutures - Surgeon 1

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03860181

00084714

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Subjects will be included if:

• They are 18 years or older;
• They are undergoing primary total shoulder arthroplasty by the principal and co-investigator.
• They are willing and have the capacity to provide informed consent;
• They expect to continue their post-operative follow up care with their operating surgeons at Medical University of South Carolina (MUSC).

Subjects will be excluded if:

• They have a unique, identifying tattoo or skin marking within 2 inches of intended site of surgical incision
• They self-report a known hypersensitivity to cyanoacrylate, formaldehyde, benzalkonium chloride, or pressure sensitive adhesive;
• They self-report or have a documented prior ipsilateral shoulder arthroplasty or other open ipsilateral shoulder surgery utilizing the delto-pectoral approach;
• Their medical record shows that they are HIV positive or otherwise immunocompromised;
• Their medical record shows a skin abnormality or dermatological condition which affects skin healing;
• They report a personal or family history of significant keloid or significant hypertrophic scar formations, or other problems with wound healing.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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89 participants in 4 patient groups

Traditional Dermabond + subcuticular sutures - Surgeon 1

Active Comparator group

Description:

Subcuticular sutures with traditional Dermabond applied to incision.

Treatment:

Procedure: Subcuticular Sutures - Surgeon 1

Metal staples - Surgeon 2

Active Comparator group

Description:

Metal staples

Treatment:

Procedure: Metal Staples - Surgeon 2

Dermabond PRINEO - Surgeon 1

Experimental group

Description:

Dermabond PRINEO System

Treatment:

Device: PRINEO - Surgeon 1

Dermabond PRINEO - Surgeon 2

Experimental group

Description:

Dermabond PRINEO System

Treatment:

Device: PRINEO - Surgeon 2