Changing of Dressing for Periprosthetic Joint Infection in Total Knee Arthroplasty
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Regularly changing group Participants will undergo dressing every 3 days by the senior wound care nurse |
Procedure: Regularly changing of dressing
Conventional dressing
|
| Active Comparator: Non-changing group Participants will not be subject to dressing change. |
Procedure: No application
No dressing change
|
Outcome Measures
Primary Outcome Measures
- Periprosthetic infection rate [90 days]
Incidence of patients to be diagnosed with periprosthetic infection according to MSIS criteria.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Participants who agreed to inclusion in the study
Exclusion Criteria:
-
Missing follow-up
-
Participants with insufficient data
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Bezmialem Vakif University
Investigators
- Principal Investigator: Orkhan Aliyev, MD, Bezmialem Vakif University
Study Documents (Full-Text)
None provided.More Information
Publications
- Berry DJ, Harmsen WS, Cabanela ME, Morrey BF. Twenty-five-year survivorship of two thousand consecutive primary Charnley total hip replacements: factors affecting survivorship of acetabular and femoral components. J Bone Joint Surg Am. 2002 Feb;84(2):171-7.
- Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5.
- Leta TH, Lygre SHL, Schrama JC, Hallan G, Gjertsen JE, Dale H, Furnes O. Outcome of Revision Surgery for Infection After Total Knee Arthroplasty: Results of 3 Surgical Strategies. JBJS Rev. 2019 Jun;7(6):e4. doi: 10.2106/JBJS.RVW.18.00084. Review.
- Söderman P, Malchau H, Herberts P. Outcome after total hip arthroplasty: Part I. General health evaluation in relation to definition of failure in the Swedish National Total Hip Arthoplasty register. Acta Orthop Scand. 2000 Aug;71(4):354-9.
- 30042020.02