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Closure After Total Shoulder Arthroplasty: Prineo vs Dermabond

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ClinicalTrials.gov Identifier: NCT03899753
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Konrad Gruson, Montefiore Medical Center

Brief Summary:

The objective is to compare two types of wound closure after total shoulder arthroplasty to determine which closure is faster, and subsequently if there are different outcomes between the two types of closures.

The objective of this study is to compare two types of wound closure after total shoulder arthroplasty procedures. A single fellowship trained shoulder surgeon will perform all procedures. It is hypothesized that participants who undergo an 2-Octyl Cyanoacrylate (OCA) mesh closure will have a faster closure time, lower cost, non-inferior complication rate, and non-inferior satisfaction scores with respect postoperative follow up and scar appearance.

Participants in the OCA mesh cohort will be compared to participants who have a closure with a running monocryl suture and dermabond. This investigation seeks to determine if OCA closure mesh closure is non-inferior to monocryl suture and dermabond in terms of operative time, cost, complications, and aesthetic appearance.

If the hypothesis is confirmed, this study will suggest that a OCA mesh closure may be used for total shoulder arthroplasty surgeries as an alternative to current conventional closures and may provide a cost benefit.


Condition or disease Intervention/treatment Phase
Shoulder Arthritis Shoulder Arthropathy Associated With Other Conditions Device: 2-Octyl Cyanoacrylate and Mesh Device: 2-Octyl Cyanoacrylate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

* Prospective Randomized Design

o After determining a participant's eligibility for inclusion, participant will be randomized to the OCA mesh group or monocryl with dermabond group. After surgery, both groups will be seen at the 2 week, 6 week, and 3 month appointments

Masking: Double (Participant, Investigator)
Masking Description: Sealed envelop determining which arm the participant is assigned to
Primary Purpose: Other
Official Title: Closure After Total Shoulder Arthroplasty: Subcuticular Closure With 2-Octyl Cyanoacrylate Versus 2-Octyl Cyanoacrylate With A Self-Adhering Mesh (Dermabond Prineo)
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: 2-Octyl Cyanoacrylate and mesh
The wound will be closed with 2-Octyl Cyanoacrylate and a mesh
Device: 2-Octyl Cyanoacrylate and Mesh
2-Octyl Cyanoacrylate and a mesh will be applied to final closure of wounds after undergoing a Total Shoulder Arthroplasty
Other Name: Prineo

Active Comparator: 2-Octyl Cyanoacrylate
The wound will be closed with just 2-Octyl Cyanoacrylate
Device: 2-Octyl Cyanoacrylate
Incisions will be closed with 2-Octyl Cyanoacrylate after undergoing a Total shoulder arthroplasty
Other Name: Dermabond




Primary Outcome Measures :
  1. Time for Incision Closure [ Time Frame: During surgery (approximately 40 minutes) ]
    A stopwatch will be used to measure the time it takes for the incision to be closed. When the surgical implants are in place and irrigation is complete, the surgeon will announce that he will start the closure and a nurse will start the stopwatch to measure how long it takes for the surgeon to close the incision.


Secondary Outcome Measures :
  1. Cost of Closure [ Time Frame: Immediately post surgery ]
    Cost of closure will be assessed by the cost of the time in the operating room and the cost of materials used to close the incision

  2. Wound Appearance [ Time Frame: At each follow up visit up to 3 months after surgery ]
    The surgeon and participant will fill out the Patient and Observer Scar Assessment Scale (POSAS). This is a survey used to assess the participant and the surgeons opinion of the appearance of the wound. The Patient and Observer Scar Assessment Scale (POSAS) is a questionnaire that was developed to assess scar quality. It consists of two separate six-item scales (Observer Scale and Patient Scale), both of which are scored on a 10-point rating scale. Each questionnaire consists of 7 questions, each graded 1 through 10. The minimum score is 7 (most like normal skin) and the maximum score is 70 (very different from normal skin). The observer is the surgeon. The observer and patient scores can then be added together to determine the collective score.

  3. Dehiscence [ Time Frame: At each follow up visit up to 3 months after surgery ]
    The wound will be assessed for dehiscence (incision opening) which will be recorded as a "yes or no". A dehiscence is defined as exposure of the underlying subcutaneous fat secondary to failure of the epidermal healing and may be accompanied by persistent wound drainage. It will be assessed by the length of the opening in centimeters and then normalized against the length of the entire incision. Furthermore, the number of wounds that open will be reported

  4. Wound drainage [ Time Frame: At first post operative visit ]
    Dressing for each participant after surgery will be regulated and changed by the surgeon at the first post op visit. Drainage will be measured by outlining the drainage on gauze onto graph paper and measuring the area as previously validated in prior studies

  5. Superficial Infection [ Time Frame: At each follow up visit up to 3 months after surgery ]
    Number of wounds with superficial skin infections will be reported

  6. Deep wound infection [ Time Frame: At each follow up visit up to 3 months after surgery ]
    Number of deep wound infections found will be reported

  7. Number of wounds that require post operative intervention [ Time Frame: At each follow up visit up to 3 months after surgery ]
    Will report the number of wounds that require post operative intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Total shoulder arthroplasty
  • Reverse total shoulder arthroplasty
  • Age 18-100
  • Single Surgeon

Exclusion Criteria:

  • Previous shoulder surgery
  • Known wound healing complications
  • DM, chronic steroid use, vascular insufficiency, morbid obesity (BMI>40), ESRD, family hx of pathologic scars
  • Patients on blood thinners (ASA 81mg ok)
  • Connective tissue disease
  • Allergy to skin adhesive
  • Mentally unable to complete questionnaires
  • Previous wound over planned incision

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): NCT03899753


Contacts
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Contact: Konrad Gruson, MD 347-577-4412 kgruson@montefiore.org
Contact: Brandon Tauberg, MD btauberg@montefiore.org

Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Konrad Gruson, MD Montefiore Medical Center

Publications:

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Responsible Party: Konrad Gruson, Attending Physician, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03899753     History of Changes
Other Study ID Numbers: 2018-9370
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Konrad Gruson, Montefiore Medical Center:
prino
total shoulder arthroplasty
wound closure

Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases