Changing of Dressing for Periprosthetic Joint Infection in Total Knee Arthroplasty

Not Applicable

• Conditions: Infection; Prosthetic Infection; Surgical Site Infection; Wound Infection
• Interventions: Procedure: Regularly changing of dressing; Procedure: No application

• Registration Number: NCT04346875
• Lead Sponsor: Bezmialem Vakif University

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.

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-12
• Study First Submitted QC: 2020-04-12
• Last Update Submitted: 2020-04-12
• Study First Posted: 2020-04-15
• Last Update Posted: 2020-04-15
• Study Start: 2020-05-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 842

Inclusion Criteria

• Participants who agreed to inclusion in the study

Exclusion Criteria

• Missing follow-up
• Participants with insufficient data

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regularly changing group	Regularly changing of dressing	Participants will undergo dressing every 3 days by the senior wound care nurse
Non-changing group	No application	Participants will not be subject to dressing change.

Primary Outcome Measures

Name	Time	Method
Periprosthetic infection rate	90 days	Incidence of patients to be diagnosed with periprosthetic infection according to MSIS criteria.