Dermabond PRINEO for Total Shoulder Arthroplasty

• ClinicalTrials.gov Identifier: NCT03860181
• Recruitment Status: Completed
• First Posted: March 1, 2019
• Results First Posted: August 25, 2021
• Last Update Posted: October 1, 2021
• Sponsor: Medical University of South Carolina
• Collaborator: Johnson & Johnson
• Information provided by (Responsible Party): Josef Eichinger, Medical University of South Carolina

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Surgical Wound; Shoulder Arthritis; Surgical Incision	Procedure: Subcuticular Sutures - Surgeon 1; Procedure: Metal Staples - Surgeon 2; Device: PRINEO - Surgeon 1; Device: PRINEO - Surgeon 2	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 89 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Investigation of a New Skin Closure Device, Dermabond PRINEO, for Total Shoulder Arthroplasty: A Randomized, Controlled Trial
• Actual Study Start Date: March 25, 2019
• Actual Primary Completion Date: June 23, 2020
• Actual Study Completion Date: June 23, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Comparison of the Total Cost of Wound Closure When Using Dermabond PRINEO Versus the Surgeon's Control. [ Time Frame: 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.
2. Comparing Patient Satisfaction Ratings Between D.PRINEO and Controls [ Time Frame: 3 months post-operatively ]
   Patient satisfaction ratings were on a scale from 0-10, where 0 = very dissatisfied and 10 = very satisfied.
3. Mean Closure Time Per Centimeter of Incision [ Time Frame: 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.

Secondary Outcome Measures :

1. Median Overall Opinion Score Reported by Operating Surgeon [ Time Frame: 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.
2. Median Wound Inflammation Score (AIRE) Reported by Operating Physician [ Time Frame: 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.
3. Median Scar Assessment (POSAS) by Operating Surgeon [ Time Frame: 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.
4. Wound Cosmesis (MHCS) Score by Operating Physician [ Time Frame: 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.
5. Differences Between Patient and Surgeon Total POSAS Scores [ Time Frame: 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.
6. Median Overall Opinion Score Reported by Plastic Surgeons [ Time Frame: 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.
7. Median Scar Assessment (POSAS) by Plastic Surgeon [ Time Frame: 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.
8. Wound Cosmesis (MHCS) Score by Plastic Surgeon [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Medical University of South Carolina

Johnson & Johnson

Investigators

• Principal Investigator: Josef Eichinger, MD; Medical University of South Carolina

  Study Documents (Full-Text)

Documents provided by Josef Eichinger, Medical University of South Carolina:

Study Protocol and Statistical Analysis Plan  [PDF] June 26, 2019

Informed Consent Form  [PDF] April 25, 2019

More Information

• Responsible Party: Josef Eichinger, Professor, Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT03860181
• Other Study ID Numbers: 00084714
• First Posted: March 1, 2019
• Results First Posted: August 25, 2021
• Last Update Posted: October 1, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Surgical Wound; Wounds and Injuries