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Trial record 2 of 5 for:    dermabond shoulder

Dermabond PRINEO for Total Shoulder Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03860181
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : April 16, 2020
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
Josef Eichinger, 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 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
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

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Arm Intervention/treatment
Active Comparator: Traditional Dermabond + subcuticular sutures
Subcuticular sutures with traditional Dermabond applied to incision.
Procedure: Subcuticular Sutures
This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.

Active Comparator: Metal staples
Metal staples
Procedure: Metal Staples
This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,

Experimental: Dermabond PRINEO
Dermabond PRINEO System
Device: PRINEO
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 Measures :
  1. Mean Time required for wound closure [ Time Frame: Up to 20 minutes during surgery for each patient. ]
    Manually recording time to wound closure during the operation using a stop watch

  2. Wound Cosmesis [ Time Frame: Up to 3 months post surgery ]
    Images of the healing wound after surgery will be assessed according to the Modified Hollander Cosmesis Scale (0 to 6, with 6 being ideal), and the

  3. Scar assessment [ 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 (0 to 10, 10 being ideal)

  4. Wound inflammation [ 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 ideal).



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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 ispilateral 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860181


Contacts
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Contact: Josef Eichinger, MD 843-876-0111 eichinge@musc.edu
Contact: Zora Mayo 843-792-5051 mayo@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Josef K Eichinger, MD         
Sponsors and Collaborators
Medical University of South Carolina
Johnson & Johnson
Investigators
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Principal Investigator: Josef Eichinger, MD Medical University of South Carolina
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Responsible Party: Josef Eichinger, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03860181    
Other Study ID Numbers: 00084714
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Surgical Wound
Wounds and Injuries