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Changing of Dressing for Periprosthetic Joint Infection in Total Knee Arthroplasty

Primary Purpose

Infection, Surgical Site Infection, Prosthetic Infection

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Regularly changing of dressing
No application
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants who agreed to inclusion in the study

Exclusion Criteria:

  • Missing follow-up
  • Participants with insufficient data

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Regularly changing group

    Non-changing group

    Arm Description

    Participants will undergo dressing every 3 days by the senior wound care nurse

    Participants will not be subject to dressing change.

    Outcomes

    Primary Outcome Measures

    Periprosthetic infection rate
    Incidence of patients to be diagnosed with periprosthetic infection according to MSIS criteria.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 12, 2020
    Last Updated
    April 12, 2020
    Sponsor
    Bezmialem Vakif University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04346875
    Brief Title
    Changing of Dressing for Periprosthetic Joint Infection in Total Knee Arthroplasty
    Official Title
    Is the Number of Dressing Changes Associated With Acute PJI Following Total Joint Arthroplasty? A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    January 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bezmialem Vakif University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary aim of the study is to compare two methods for a relationship with total knee infection: regular changing of dressings and not changing dressings.
    Detailed Description
    Periprosthetic joint infection (PJI) is one of the most dreaded complications that occur after total joint arthroplasty. Periprosthetic joint infection remains an uncommon yet devastating complication that continues to influence the outcome of total joint arthroplasty. (1-4) Although different dressing methods have been described, the effect of changing the frequency of conventional dressings on PJI is curious. After obtaining informed consent from all participants, parallel-group randomization will be performed with the help of a computer. The first dressing of all participants will be done in the operating room using the same materials. No drains will be used in any patient. Then, according to the randomization, the procedures will be adjusted by the wound care nurse with the patient. All on-study and outcome data will be collected by the study staff blinded to study group assignment. The dressing group participants will be dressed by the same wound care nurse during the discharge. The dressing group participants will be dressed by the same wound care nurse in an outpatient service every three days using the same material. The total dressing number will be in the dressing group participant 5 times. Both group participants will be evaluated in the outpatient service after 2 weeks. Subsequently, all participants will be invited to check-in at the end of each month. All participants will be evaluated according to MSIS criteria in terms of superficial and deep periprosthetic infection. The primary endpoint is to detect the difference between the incidence of periprosthetic infection after the regular dressing change and the incidence of the dressing unchanged group. In the secondary endpoint, it is to determine whether dressing change is an independent factor with multiple logistic regression test.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infection, Surgical Site Infection, Prosthetic Infection, Wound Infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Single-blind
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    842 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Regularly changing group
    Arm Type
    Experimental
    Arm Description
    Participants will undergo dressing every 3 days by the senior wound care nurse
    Arm Title
    Non-changing group
    Arm Type
    Active Comparator
    Arm Description
    Participants will not be subject to dressing change.
    Intervention Type
    Procedure
    Intervention Name(s)
    Regularly changing of dressing
    Intervention Description
    Conventional dressing
    Intervention Type
    Procedure
    Intervention Name(s)
    No application
    Intervention Description
    No dressing change
    Primary Outcome Measure Information:
    Title
    Periprosthetic infection rate
    Description
    Incidence of patients to be diagnosed with periprosthetic infection according to MSIS criteria.
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants who agreed to inclusion in the study Exclusion Criteria: Missing follow-up Participants with insufficient data
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Orkhan Aliyev, MD
    Phone
    +905059917419
    Email
    orkhanaliyev@outlook.com.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Orkhan Aliyev, MD
    Organizational Affiliation
    Bezmialem Vakif University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    All IPD
    Citations:
    PubMed Identifier
    17403800
    Citation
    Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
    Results Reference
    background
    PubMed Identifier
    31188156
    Citation
    Leta TH, Lygre SHL, Schrama JC, Hallan G, Gjertsen JE, Dale H, Furnes O. Outcome of Revision Surgery for Infection After Total Knee Arthroplasty: Results of 3 Surgical Strategies. JBJS Rev. 2019 Jun;7(6):e4. doi: 10.2106/JBJS.RVW.18.00084.
    Results Reference
    background
    PubMed Identifier
    11861721
    Citation
    Berry DJ, Harmsen WS, Cabanela ME, Morrey BF. Twenty-five-year survivorship of two thousand consecutive primary Charnley total hip replacements: factors affecting survivorship of acetabular and femoral components. J Bone Joint Surg Am. 2002 Feb;84(2):171-7. doi: 10.2106/00004623-200202000-00002.
    Results Reference
    background
    PubMed Identifier
    11028882
    Citation
    Soderman P, Malchau H, Herberts P. Outcome after total hip arthroplasty: Part I. General health evaluation in relation to definition of failure in the Swedish National Total Hip Arthoplasty register. Acta Orthop Scand. 2000 Aug;71(4):354-9. doi: 10.1080/000164700317393330.
    Results Reference
    background

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    Changing of Dressing for Periprosthetic Joint Infection in Total Knee Arthroplasty

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