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

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

Detailed Description
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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.

Official Title
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A Single-center, Phase IV, Randomized, Prospective Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications

Conditions
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Joint Disease, Arthropathy

Intervention / Treatment
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* Device: Zipper surgical skin closure
* Other: Monocryl + Dermabond
* Other: Polyester mesh + Dermabond


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are undergoing joint arthroplasty Exclusion Criteria: Treatment of total joint replacement surgery at an outside institution

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zipper surgical skin closure<br>Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty | Device: Zipper surgical skin closure<br>* 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.<br>|
| Active Comparator: Monocryl + Dermabond<br>Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today. | Other: Monocryl + Dermabond<br>* conventional sutures and skin adhesive glue<br>|
| Active Comparator: Polyester mesh + Dermabond<br>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<br>* conventional sutures and skin adhesive glue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) for Pain | The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity along a horizontal line, and this rating is then measured from the left edge. The total range of score is 0-10; the higher the score the worse the pain (0 = no pain, 10 = worst pain imaginable). | 4 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Monocryl, Dermabond, Polyester mesh, Joint Disease, Arthropathy, Joint Replacement