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

NCT ID: NCT03134209

Last Updated: 2021-09-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-26

Study Completion Date

2020-08-31

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.

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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.

Conditions

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Joint Disease Arthropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zipper surgical skin closure

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

Group Type EXPERIMENTAL

Zipper surgical skin closure

Intervention Type DEVICE

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.

Monocryl + Dermabond

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

Group Type ACTIVE_COMPARATOR

Monocryl + Dermabond

Intervention Type OTHER

conventional sutures and skin adhesive glue

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

Group Type ACTIVE_COMPARATOR

Polyester mesh + Dermabond

Intervention Type OTHER

conventional sutures and skin adhesive glue

Interventions

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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.

Intervention Type DEVICE

Monocryl + Dermabond

conventional sutures and skin adhesive glue

Intervention Type OTHER

Polyester mesh + Dermabond

conventional sutures and skin adhesive glue

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ran Schwarzkopf

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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16-02020

Identifier Type: -

Identifier Source: org_study_id

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