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

Primary Purpose

Joint Disease, Arthropathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zipper surgical skin closure
Monocryl + Dermabond
Polyester mesh + Dermabond
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Joint Disease focused on measuring Monocryl, Dermabond, Polyester mesh, Joint Disease, Arthropathy, Joint Replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are undergoing joint arthroplasty

Exclusion Criteria:

  • Treatment of total joint replacement surgery at an outside institution

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Zipper surgical skin closure

Monocryl + Dermabond

Polyester mesh + Dermabond

Arm Description

Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty

Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
April 26, 2017
Last Updated
September 13, 2021
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03134209
Brief Title
A Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications
Official Title
A Single-center, Phase IV, Randomized, Prospective Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 26, 2017 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Disease, Arthropathy
Keywords
Monocryl, Dermabond, Polyester mesh, Joint Disease, Arthropathy, Joint Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zipper surgical skin closure
Arm Type
Experimental
Arm Description
Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty
Arm Title
Monocryl + Dermabond
Arm Type
Active Comparator
Arm Description
Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today.
Arm Title
Polyester mesh + Dermabond
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Zipper surgical skin closure
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Monocryl + Dermabond
Intervention Description
conventional sutures and skin adhesive glue
Intervention Type
Other
Intervention Name(s)
Polyester mesh + Dermabond
Intervention Description
conventional sutures and skin adhesive glue
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) for Pain
Description
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).
Time Frame
4 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are undergoing joint arthroplasty Exclusion Criteria: Treatment of total joint replacement surgery at an outside institution
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ran Schwarzkopf
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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