Changing of Dressing for Periprosthetic Joint Infection in Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Is the Number of Dressing Changes Associated With Acute PJI Following Total Joint Arthroplasty? A Randomized Clinical Trial

Conditions
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Infection, Surgical Site Infection, Prosthetic Infection, Wound Infection

Intervention / Treatment
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* Procedure: Regularly changing of dressing
* Procedure: No application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who agreed to inclusion in the study Exclusion Criteria: Missing follow-up Participants with insufficient data

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-blind
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regularly changing group<br>Participants will undergo dressing every 3 days by the senior wound care nurse | Procedure: Regularly changing of dressing<br>* Conventional dressing<br>|
| Active Comparator: Non-changing group<br>Participants will not be subject to dressing change. | Procedure: No application<br>* No dressing change<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periprosthetic infection rate | Incidence of patients to be diagnosed with periprosthetic infection according to MSIS criteria. | 90 days |