Dermabond PRINEO for Total Shoulder Arthroplasty

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-25

Study Completion Date

2020-06-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Surgical Wound Shoulder Arthritis Surgical Incision

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Traditional Dermabond + subcuticular sutures - Surgeon 1

Subcuticular sutures with traditional Dermabond applied to incision.

Group Type ACTIVE_COMPARATOR

Subcuticular Sutures - Surgeon 1

Intervention Type PROCEDURE

This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.

Metal staples - Surgeon 2

Metal staples

Group Type ACTIVE_COMPARATOR

Metal Staples - Surgeon 2

Intervention Type PROCEDURE

This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,

Dermabond PRINEO - Surgeon 1

Dermabond PRINEO System

Group Type EXPERIMENTAL

PRINEO - Surgeon 1

Intervention Type DEVICE

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.

Dermabond PRINEO - Surgeon 2

Dermabond PRINEO System

Group Type EXPERIMENTAL

PRINEO - Surgeon 2

Intervention Type DEVICE

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.

Interventions

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Subcuticular Sutures - Surgeon 1

This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.

Intervention Type PROCEDURE

Metal Staples - Surgeon 2

This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,

Intervention Type PROCEDURE

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No