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Dermabond PRINEO for Total Shoulder Arthroplasty

Primary Purpose

Surgical Wound, Shoulder Arthritis, Surgical Incision

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Subcuticular Sutures - Surgeon 1
Metal Staples - Surgeon 2
PRINEO - Surgeon 1
PRINEO - Surgeon 2
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

Traditional Dermabond + subcuticular sutures - Surgeon 1

Metal staples - Surgeon 2

Dermabond PRINEO - Surgeon 1

Dermabond PRINEO - Surgeon 2

Arm Description

Subcuticular sutures with traditional Dermabond applied to incision.

Metal staples

Dermabond PRINEO System

Dermabond PRINEO System

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 27, 2019
Last Updated
September 2, 2021
Sponsor
Medical University of South Carolina
Collaborators
Johnson & Johnson
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1. Study Identification

Unique Protocol Identification Number
NCT03860181
Brief Title
Dermabond PRINEO for Total Shoulder Arthroplasty
Official Title
Investigation of a New Skin Closure Device, Dermabond PRINEO, for Total Shoulder Arthroplasty: A Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
June 23, 2020 (Actual)
Study Completion Date
June 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
Johnson & Johnson

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound, Shoulder Arthritis, Surgical Incision

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Dermabond + subcuticular sutures - Surgeon 1
Arm Type
Active Comparator
Arm Description
Subcuticular sutures with traditional Dermabond applied to incision.
Arm Title
Metal staples - Surgeon 2
Arm Type
Active Comparator
Arm Description
Metal staples
Arm Title
Dermabond PRINEO - Surgeon 1
Arm Type
Experimental
Arm Description
Dermabond PRINEO System
Arm Title
Dermabond PRINEO - Surgeon 2
Arm Type
Experimental
Arm Description
Dermabond PRINEO System
Intervention Type
Procedure
Intervention Name(s)
Subcuticular Sutures - Surgeon 1
Intervention Description
This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
Intervention Type
Procedure
Intervention Name(s)
Metal Staples - Surgeon 2
Intervention Description
This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
Intervention Type
Device
Intervention Name(s)
PRINEO - Surgeon 1
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PRINEO - Surgeon 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of the Total Cost of Wound Closure When Using Dermabond PRINEO Versus the Surgeon's Control.
Description
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
Title
Comparing Patient Satisfaction Ratings Between D.PRINEO and Controls
Description
Patient satisfaction ratings were on a scale from 0-10, where 0 = very dissatisfied and 10 = very satisfied.
Time Frame
3 months post-operatively
Title
Mean Closure Time Per Centimeter of Incision
Description
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 Outcome Measure Information:
Title
Median Overall Opinion Score Reported by Operating Surgeon
Description
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
Title
Median Wound Inflammation Score (AIRE) Reported by Operating Physician
Description
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
Title
Median Scar Assessment (POSAS) by Operating Surgeon
Description
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.
Time Frame
Up to 3 months post surgery
Title
Wound Cosmesis (MHCS) Score by Operating Physician
Description
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.
Time Frame
Up to 3 months post surgery
Title
Differences Between Patient and Surgeon Total POSAS Scores
Description
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.
Time Frame
3 months post-operatively
Title
Median Overall Opinion Score Reported by Plastic Surgeons
Description
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.
Time Frame
Up to 3 months
Title
Median Scar Assessment (POSAS) by Plastic Surgeon
Description
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.
Time Frame
Up to 3 months post surgery
Title
Wound Cosmesis (MHCS) Score by Plastic Surgeon
Description
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.
Time Frame
Up to 3 months post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josef Eichinger, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Dermabond PRINEO for Total Shoulder Arthroplasty

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