Dermabond PRINEO for Total Shoulder Arthroplasty

Study Overview
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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.

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

Conditions
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Surgical Wound, Shoulder Arthritis, Surgical Incision

Intervention / Treatment
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* Procedure: Subcuticular Sutures - Surgeon 1
* Procedure: Metal Staples - Surgeon 2
* Device: PRINEO - Surgeon 1
* Device: PRINEO - Surgeon 2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |