Changing of Dressing for Periprosthetic Joint Infection in Total Knee Arthroplasty
NCT ID: NCT04346875
Last Updated: 2020-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
842 participants
INTERVENTIONAL
2020-05-01
2022-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Regularly changing group
Participants will undergo dressing every 3 days by the senior wound care nurse
Regularly changing of dressing
Conventional dressing
Non-changing group
Participants will not be subject to dressing change.
No application
No dressing change
Interventions
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Regularly changing of dressing
Conventional dressing
No application
No dressing change
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Participants with insufficient data
18 Years
100 Years
ALL
No
Sponsors
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Bezmialem Vakif University
OTHER
Responsible Party
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Orkhan Aliyev
Residents Doctor in Orthopedics Department
Principal Investigators
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Orkhan Aliyev, MD
Role: PRINCIPAL_INVESTIGATOR
Bezmialem Vakif University
Central Contacts
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References
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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. doi: 10.2106/JBJS.F.00222.
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.
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. doi: 10.2106/00004623-200202000-00002.
Soderman 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. doi: 10.1080/000164700317393330.
Other Identifiers
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30042020.02
Identifier Type: -
Identifier Source: org_study_id
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