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

NCT03134209 | Completed Results FDA Device

• 1 other identifier: 16-02020
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Joint Disease; Arthropathy

Keywords

Monocryl; Dermabond; Polyester mesh; Joint Disease; Arthropathy; Joint Replacement

Outcome Measures

Primary Outcomes (1)

• 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).

  4 Days

Study Arms (3)

Zipper surgical skin closure

EXPERIMENTAL

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

Device: Zipper surgical skin closure

Monocryl + Dermabond

ACTIVE COMPARATOR

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

Other: Monocryl + Dermabond

Polyester mesh + Dermabond

ACTIVE COMPARATOR

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

Interventions

Zipper surgical skin closure 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.

Zipper surgical skin closure

Monocryl + Dermabond OTHER

conventional sutures and skin adhesive glue

Monocryl + Dermabond

Polyester mesh + Dermabond OTHER

conventional sutures and skin adhesive glue

Polyester mesh + Dermabond

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are undergoing joint arthroplasty

You may not qualify if:

• Treatment of total joint replacement surgery at an outside institution

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Joint Diseases

Interventions

glycolide E-caprolactone copolymer; octyl 2-cyanoacrylate

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Results Point of Contact

• Title: Ran Schwarzkopf, MD
• Organization: NYU Langone Health

Ran.Schwarzkopf@nyulangone.org

646-356-9405

Study Officials

• Ran Schwarzkopf

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: April 28, 2017
• Study Start: April 26, 2017
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: September 14, 2021
• Results First Posted: September 14, 2021

Record last verified: 2021-09

Locations

US (1)