NCT04346875

Changing of Dressing for Periprosthetic Joint Infection in Total Knee Arthroplasty

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 842 (estimated)
• Sponsor: Bezmialem Vakif University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infection
• Surgical Site Infection
• Prosthetic Infection
• Wound Infection

Interventions

Type	Name	Description
PROCEDURE	Regularly changing of dressing	Conventional dressing
PROCEDURE	No application	No dressing change

Timeline

• Start date: 2020-05-01
• Primary completion: 2021-12-31
• Completion: 2022-01-31
• First posted: 2020-04-15
• Last updated: 2020-04-15