Changing of Dressing for Periprosthetic Joint Infection in Total Knee Arthroplasty

Bezmialem Vakif University

Status: Unknown

Conditions: Infection; Surgical Site Infection; Prosthetic Infection; Wound Infection

Treatments: Procedure: No application; Procedure: Regularly changing of dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT04346875

30042020.02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 842 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who agreed to inclusion in the study

Exclusion criteria

• Missing follow-up
• Participants with insufficient data

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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842 participants in 2 patient groups

Regularly changing group

Experimental group

Description:

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

Treatment:

Procedure: Regularly changing of dressing

Non-changing group

Active Comparator group

Description:

Participants will not be subject to dressing change.

Treatment:

Procedure: No application