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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04346875
Enrollment
842
Registered
2020-04-15
Start date
2020-05-01
Completion date
2022-01-31
Last updated
2020-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Prosthetic Infection, Surgical Site Infection, Wound Infection

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.

Interventions

PROCEDURERegularly changing of dressing

Conventional dressing

No dressing change

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Single-blind

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Participants who agreed to inclusion in the study

Exclusion criteria

* Missing follow-up * Participants with insufficient data

Design outcomes

Primary

MeasureTime frameDescription
Periprosthetic infection rate90 daysIncidence of patients to be diagnosed with periprosthetic infection according to MSIS criteria.

Contacts

Primary ContactOrkhan Aliyev, MD
orkhanaliyev@outlook.com.tr+905059917419

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026