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Trial record 35 of 26553 for:    Anti-Infective Agents

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

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ClinicalTrials.gov Identifier: NCT03345771
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Combination Product: Antimicrobial Barrier Dressing Device: Negative Pressure Wound Therapy (NPWT) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antimicrobial Barrier Dressing Versus Closed-incision Negative Pressure Therapy in the Obese Primary Total Joint Arthroplasty
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: PICO




Primary Outcome Measures :
  1. Visual Analog Scale (VAS) pain score [ Time Frame: Day 8 ]
    0 = worst possible scar, 100 = best possible scar

  2. Wound Evaluation Scale (WES) [ Time Frame: Day 8 ]

    Wound Evaluation Scale*

    1. Stepoff borders (0 for yes, 1 for no)
    2. Contour irregularity-puckering
    3. Scar width-greater than 2 mm
    4. Edge inversion-sinking, curling
    5. Inflammation-redness, discharge
    6. Overall cosmesis (0 = poor, 1 = acceptable) *6/6 = optimal wound healing.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345771


Contacts
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Contact: Afshin Anoushiravani 212 598 6146 Afshin.Anoushiravani@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Afshin Anoushiravani    212-598-6146    Afshin.Anoushiravani@nyumc.org   
Principal Investigator: William Long, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: William Long, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03345771     History of Changes
Other Study ID Numbers: 17-00496
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Infective Agents
Anti-Bacterial Agents