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

• ClinicalTrials.gov Identifier: NCT03134209
• Recruitment Status: Completed
• First Posted: April 28, 2017
• Last Update Posted: February 2, 2021
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 160 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
• Actual Primary Completion Date: August 31, 2020
• Actual Study Completion Date: August 31, 2020

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, New York

New York University School of Medicine

New York, New York, United States, 10016

Sponsors and Collaborators

NYU Langone Health

Investigators

• Principal Investigator: Ran Schwarzkopf; NYU Langone Health

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03134209
• Other Study ID Numbers: 16-02020
• First Posted: April 28, 2017
• Last Update Posted: February 2, 2021
• Last Verified: February 2021

• 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:

Joint Diseases; Musculoskeletal Diseases