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Completed

NCT Number: NCT03860181

Dermabond PRINEO for Total Shoulder Arthroplasty

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.

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Key information

Conditions

Surgical Wound Shoulder Arthritis Surgical Incision Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Subcuticular Sutures - Surgeon 1

Procedure

This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.

Metal Staples - Surgeon 2

Procedure

This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,

PRINEO - Surgeon 1

Device

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.

PRINEO - Surgeon 2

Device

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Johnson & Johnson

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 1, 2019
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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