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

Not Applicable

Completed

• Conditions: Arthropathy; Joint Disease
• Interventions: Other: Monocryl + Dermabond; Other: Polyester mesh + Dermabond; Device: Zipper surgical skin closure

• Registration Number: NCT03134209
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2017-04-26
• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-04-28
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Results First Submitted: 2021-08-17
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-13
• Last Update Submitted: 2021-09-13
• Results First Posted: 2021-09-14
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Patients who are undergoing joint arthroplasty

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Exclusion Criteria

• Treatment of total joint replacement surgery at an outside institution

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monocryl + Dermabond	Monocryl + Dermabond	Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today.
Polyester mesh + Dermabond	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
Zipper surgical skin closure	Zipper surgical skin closure	Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) for Pain	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).

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States