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A Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications

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: NCT03134209
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
A single-center, phase IV, randomized, prospective study investigating the efficacy of various wound closure devices in reducing postoperative wound complications.

Condition or disease Intervention/treatment Phase
Joint Disease Arthropathy Device: Zipper surgical skin closure Other: Monocryl + Dermabond Other: Polyester mesh + Dermabond Not Applicable

Detailed Description:
The zipper wound technology is a new wound closure device that is an alternative to the commonly used conventional staples and sutures. The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin. The other treatment groups include monocryl + Dermabond (conventional sutures and skin adhesive glue) and polyester mesh + Dermabond. All products have been FDA approved. A randomized control trial will provide the highest level of evidence without altering the potential risks to the patient as all three wound closure techniques have been found to have comparable complication rates. The three different treatment devices will be administered following the normal standard of care. All three wound closure devices are currently being used at NYULMC. No modifications to the normal standard of practice other than the randomization process will be implemented. Given the nature of the application of the wound closure device, which will be visible to the surgeon at the time of application and the patient postoperatively, the study will not be blinded to either the surgeon or the patient. Prior to discharge, a blinded plastic surgeon will be asked to assess the wound based on comesis and overall quality of wound healing.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty will be compared to two groups: 1) Monocryl + Dermabond 2) Polyester mesh + Dermabond
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-center, Phase IV, Randomized, Prospective Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications
Actual Study Start Date : April 26, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Zipper surgical skin closure
Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty
Device: Zipper surgical skin closure
The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin.

Active Comparator: Monocryl + Dermabond
Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today.
Other: Monocryl + Dermabond
conventional sutures and skin adhesive glue

Active Comparator: Polyester mesh + Dermabond
The polyester plus Dermabond closure techniques combines the OCA topical skin adhesive with a flexible, self-adhesive polyester mesh that has proven to reduce wound cosure times and have a significant greater skin holding strength than skin staples or subcuticular sutures in one study
Other: Polyester mesh + Dermabond
conventional sutures and skin adhesive glue




Primary Outcome Measures :
  1. Visual Analog Scale for Pain (VAS Pain) [ Time Frame: 4 Days ]
    The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.



Information from the National Library of Medicine

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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

Inclusion Criteria:

  • Patients who are undergoing joint arthroplasty

Exclusion Criteria:

  • Treatment of total joint replacement surgery at an outside institution

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): NCT03134209


Contacts
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Contact: Pankaj Patel 646 356 9405 pankaj.patel@nyumc.org
Contact: Kelvin Kim 646 356 9405 kelvin.kim@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Pankaj Patel       pankaj.patel@nyumc.org   
Principal Investigator: Ran Schwarzkopf, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Ran Schwarzkopf NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03134209    
Other Study ID Numbers: 16-02020
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019

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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.: No
Keywords provided by NYU Langone Health:
Monocryl
Dermabond
Polyester mesh
Joint Disease
Arthropathy
Joint Replacement
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases