Dermabond PRINEO for Total Shoulder Arthroplasty

Not Applicable

Completed

• Conditions: Surgical Incision; Shoulder Arthritis; Surgical Wound
• Interventions: Device: PRINEO - Surgeon 1; Device: PRINEO - Surgeon 2; Procedure: Subcuticular Sutures - Surgeon 1; Procedure: Metal Staples - Surgeon 2

• Registration Number: NCT03860181
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-01
• Study Start: 2019-03-25
• Primary Completion: 2020-06-23
• Study Completion: 2020-06-23
• Results First Submitted: 2021-06-22
• Results First Submitted QC: 2021-08-21
• Results First Posted: 2021-08-25
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dermabond PRINEO - Surgeon 1	PRINEO - Surgeon 1	Dermabond PRINEO System
Dermabond PRINEO - Surgeon 2	PRINEO - Surgeon 2	Dermabond PRINEO System
Traditional Dermabond + subcuticular sutures - Surgeon 1	Subcuticular Sutures - Surgeon 1	Subcuticular sutures with traditional Dermabond applied to incision.
Metal staples - Surgeon 2	Metal Staples - Surgeon 2	Metal staples

Primary Outcome Measures

Name	Time	Method
Comparing Patient Satisfaction Ratings Between D.PRINEO and Controls	3 months post-operatively	Patient satisfaction ratings were on a scale from 0-10, where 0 = very dissatisfied and 10 = very satisfied.
Mean Closure Time Per Centimeter of Incision	Immediate/at time of surgery	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.
Comparison of the Total Cost of Wound Closure When Using Dermabond PRINEO Versus the Surgeon's Control.	3 months post-operative	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.

Secondary Outcome Measures

Name	Time	Method
Median Scar Assessment (POSAS) by Plastic Surgeon	Up to 3 months post surgery	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.
Median Overall Opinion Score Reported by Operating Surgeon	Up to 3 months	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.
Median Overall Opinion Score Reported by Plastic Surgeons	Up to 3 months	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.
Wound Cosmesis (MHCS) Score by Plastic Surgeon	Up to 3 months post surgery	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.
Median Wound Inflammation Score (AIRE) Reported by Operating Physician	Up to 3 months post surgery	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.
Median Scar Assessment (POSAS) by Operating Surgeon	Up to 3 months post surgery	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.
Wound Cosmesis (MHCS) Score by Operating Physician	Up to 3 months post surgery	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.
Differences Between Patient and Surgeon Total POSAS Scores	3 months post-operatively	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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States