Antimicrobial Barrier Dressing Versus Closed-incision Negative Pressure Therapy in the Obese Primary Total Joint Arthroplasty

March 29, 2022 updated by: NYU Langone Health
The purpose of this study is to determine whether an occlusive antimicrobial barrier dressing or portable negative pressure wound dressing is superior in preventing wound complications and infection rates in obese patients undergoing total joint arthroplasty (TJA). Approximately 240 subjects (120 for total knee arthroplasty and 120 for total hip arthroplasty) will be enrolled to evaluate the outcomes associated with silver impregnated dressings and negative pressure wound therapy (NPWT) in treating this subset of patients and analyze the cost benefit of each.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Those identified at pre-operative testing to have an elevated BMI (> 35)

Exclusion Criteria:

  • Active infection
  • previous scar or wound healing complication
  • post traumatic degenerative joint disease (DJD) with hardware
  • revision surgery
  • inflammatory arthritis
  • anticoagulation outside of the standard of care.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Antimicrobial Barrier Dressing
postoperative wound dressing with either anti-microbial dressing placed in the operating room from surgery to postoperative day 7
Combination product: Antimicrobial Barrier Dressing
Ionic Silver is a soft, nonwoven pad or ribbon that features the gelling benefits of Hydrofiber technology plus antimicrobial ionic silver.
Other Names:
  • AQUACEL Ag Hydrofiber Dressing
Active Comparator: Closed-incision Negative Pressure Therapy
portable NPWT device placed in the operating room from surgery to postoperative day 7
Device: Negative Pressure Wound Therapy (NPWT)
PICO provides suction known as negative Pressure wound Therapy (NPWT) which draws out excess fluid from a wound and protects the injured area from getting dirty to ultimately help promote healing. PICO consists of an nPwT pump connected to an absorbent gentle adhesive dressing
Other Names:
  • PICO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) Pain Score
Time Frame: Day 8
A patient is asked to indicate his/her perceived scar severity along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (worst possible scar) to 100 (best possible scar); the higher the score, the better the scarring.
Day 8
Wound Evaluation Scale (WES)
Time Frame: Day 8
WES is a 6-item scale. Items 1-5 are scored 0 (yes) or 1 (no), and item 6 is scored 0 (poor) or 1 (acceptable). The total score range is 0-6; the higher the score, the more optimal the wound healing.
Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Ran Schwarzkopf, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2017

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

November 14, 2017

First Submitted That Met QC Criteria

November 14, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-00496

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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