Changing of Dressing for Periprosthetic Joint Infection in Total Knee Arthroplasty

NCT04346875 | Unknown

• 1 other identifier: 30042020.02
• Study Type: interventional
• Target: 842
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infection; Surgical Site Infection; Prosthetic Infection; Wound Infection

Outcome Measures

Primary Outcomes (1)

• Periprosthetic infection rate

  Incidence of patients to be diagnosed with periprosthetic infection according to MSIS criteria.

  90 days

Study Arms (2)

Regularly changing group

EXPERIMENTAL

Participants will undergo dressing every 3 days by the senior wound care nurse

Procedure: Regularly changing of dressing

Non-changing group

ACTIVE COMPARATOR

Participants will not be subject to dressing change.

Procedure: No application

Interventions

Regularly changing of dressing PROCEDURE

Conventional dressing

Regularly changing group

No application PROCEDURE

No dressing change

Non-changing group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Missing follow-up
• Participants with insufficient data

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Related Publications (4)

• 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.

  PMID: 17403800 BACKGROUND

• 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.

  PMID: 31188156 BACKGROUND

• 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.

  PMID: 11861721 BACKGROUND

• 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.

  PMID: 11028882 BACKGROUND

MeSH Terms

Conditions

Infections; Surgical Wound Infection; Wound Infection

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Orkhan Aliyev, MD

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Orkhan Aliyev, MD

CONTACT

+905059917419; orkhanaliyev@outlook.com.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residents Doctor in Orthopedics Department

Model Details: Single-blind

Study Record Dates

• First Submitted: April 12, 2020
• First Posted: April 15, 2020
• Study Start: May 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: April 15, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE