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

NYU Langone Health

Status: Completed

Conditions: Joint Disease; Arthropathy

Treatments: Other: Monocryl + Dermabond; Other: Polyester mesh + Dermabond; Device: Zipper surgical skin closure

Study type: Interventional

Funder types: Other

Identifiers

NCT03134209

16-02020

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are undergoing joint arthroplasty

Exclusion criteria

• Treatment of total joint replacement surgery at an outside institution

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 3 patient groups

Zipper surgical skin closure

Experimental group

Description:

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

Treatment:

Device: Zipper surgical skin closure

Monocryl + Dermabond

Active Comparator group

Description:

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

Treatment:

Other: Monocryl + Dermabond

Polyester mesh + Dermabond

Active Comparator group

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

Treatment:

Other: Polyester mesh + Dermabond