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