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Clinical Trials/NCT03134209
NCT03134209
Completed
Not Applicable

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

NYU Langone Health1 site in 1 country160 target enrollmentApril 26, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Joint Disease
Sponsor
NYU Langone Health
Enrollment
160
Locations
1
Primary Endpoint
Visual Analog Scale (VAS) for Pain
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
April 26, 2017
End Date
August 31, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients who are undergoing joint arthroplasty

Exclusion Criteria

  • Treatment of total joint replacement surgery at an outside institution

Outcomes

Primary Outcomes

Visual Analog Scale (VAS) for Pain

Time Frame: 4 Days

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).

Study Sites (1)

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