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
About this trial
This is an interventional prevention trial for Infection
Eligibility Criteria
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
NCT ID
NCT04346875
First Posted
April 12, 2020
Last Updated
April 12, 2020
Sponsor
Bezmialem Vakif University
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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