Dermabond PRINEO for Total Shoulder Arthroplasty

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

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 Overview

• Status: Completed
• Conditions: Surgical Wound; Surgical Incision; Shoulder Arthritis
• Intervention / Treatment: Procedure: Subcuticular Sutures - Surgeon 1; Procedure: Metal Staples - Surgeon 2; Device: PRINEO - Surgeon 1; Device: PRINEO - Surgeon 2

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional Dermabond + subcuticular sutures - Surgeon 1; Subcuticular sutures with traditional Dermabond applied to incision.	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.
Active Comparator: Metal staples - Surgeon 2; Metal staples	Procedure: Metal Staples - Surgeon 2; This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
Experimental: Dermabond PRINEO - Surgeon 1; Dermabond PRINEO System	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.
Experimental: Dermabond PRINEO - Surgeon 2; Dermabond PRINEO System	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Immediate/at time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 3 months post surgery
Median Scar Assessment (POSAS) by Operating Surgeon	Images of the healing wound will be assessed according to the Patient and Observer Scar Assessment Scale (POSAS, where there are six components each ranging between 1-10 with 10 representing the worst outcome, and each of those six components were summed for these results, having a final range of 6-60) by the operating surgeon.	Up to 3 months post surgery
Wound Cosmesis (MHCS) Score by Operating Physician	Evaluation of the wound after surgery will be assessed according to the Modified Hollander Cosmesis Scale (0 to 6, with 0 being ideal) by the operating physician.	Up to 3 months post surgery
Differences Between Patient and Surgeon Total POSAS Scores	POSAS scores can range from 1-10, where 1 is like normal skin, and 10 is worst scar imaginable, and has six components. Each component (range of 1-10) was summed up to get a final score (range of 6-60) for each participant. Differences were calculated as the participant's Patient and Observer Scar Assessment Scale (POSAS) score minus the physician POSAS score, with a negative difference signifying that the patients thought more highly of the scars than the physicians since lower POSAS scores are more favorable.	3 months post-operatively
Median Overall Opinion Score Reported by Plastic Surgeons	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 an independent plastic surgeon.	Up to 3 months
Median Scar Assessment (POSAS) by Plastic Surgeon	Images of the healing wound will be assessed according to the Patient and Observer Scar Assessment Scale (POSAS, includes six measurements ranging from 0 to 10, 10 being ideal, where the total of the six measurements is what is reported) by an independent plastic surgeon. This POSAS total score would then range from 6-60.	Up to 3 months post surgery
Wound Cosmesis (MHCS) Score by Plastic Surgeon	Evaluation of the wound after surgery will be assessed according to the Modified Hollander Cosmesis Scale (0 to 6, with 0 being ideal) by an independent plastic surgeon.	Up to 3 months post surgery

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Johnson & Johnson
• Investigators: Principal Investigator: Josef Eichinger, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Actual): June 23, 2020
• Study Completion (Actual): June 23, 2020

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 00084714

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes