Dermabond PRINEO for Total Shoulder Arthroplasty

Medical University of South Carolina89 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Surgical Wound Shoulder Arthritis Surgical Incision

Interventions

Subcuticular Sutures - Surgeon 1PROCEDURE

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

Metal Staples - Surgeon 2PROCEDURE

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

PRINEO - Surgeon 1DEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Comparison of the Total Cost of Wound Closure When Using Dermabond PRINEO Versus the Surgeon's Control.

Closure cost was calculated by evaluating the cost of wound closure products ($) per patient, plus the cost of the operating room ($) per minute, multiplied by the closure time (minutes) per centimeter of incision length, then multiplied by the average incision length (cm) per patient.

Time frame: 3 months post-operative

Comparing Patient Satisfaction Ratings Between D.PRINEO and Controls

Patient satisfaction ratings were on a scale from 0-10, where 0 = very dissatisfied and 10 = very satisfied.

Time frame: 3 months post-operatively

Mean Closure Time Per Centimeter of Incision

This closure time was measured from the first stitch for closure to the application of the wound dressing. The incision length was measured immediately after closure.

Time frame: Immediate/at time of surgery

Secondary Outcomes

Median Overall Opinion Score Reported by Operating Surgeon

Overall Opinion was on a scale 1 - 10, where lower scores are viewed more favorably with 1=normal skin and 10=very different compared to adjacent skin, which was evaluated by the operating physician.

Time frame: Up to 3 months

Median Wound Inflammation Score (AIRE) Reported by Operating Physician

Images of the healing wound will be assessed according to the Acute Inflammatory Response Evaluation score (0 to 3, 0 being the lowest amount of inflammation and 3 represents the highest amount of inflammation) by the operating physician.

Time frame: Up to 3 months post surgery

Median Scar Assessment (POSAS) by Operating Surgeon

Data from ClinicalTrials.gov

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