Changing of Dressing for Periprosthetic Joint Infection i... | NCT04346875

Studies
Changing of Dressing for Periprosthetic Joint Infection in Total Knee Arthroplasty

NCT04346875

Sponsor

Bezmialem Vakif University

Status

Unknown status

Last Update Posted

Apr 15, 2020Actual

Enrollment

842Estimated

Phase

Not Applicable

Conditions

Infection
Surgical Site Infection
Prosthetic Infection
Wound Infection

Interventions

Regularly changing of dressing
No application

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2020Estimated

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Jan 31, 2022Estimated

First Submitted Date

Apr 12, 2020

First Submission Date that Met QC Criteria

Apr 12, 2020

First Posted Date

Apr 15, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2020

Last Update Posted Date

Apr 15, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Orkhan Aliyev, Residents Doctor in Orthopedics Department, Bezmialem Vakif UniversityPrincipal Investigator

Lead Sponsor

Bezmialem Vakif UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

842Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Regularly changing of dressing	Procedure	Conventional dressing	Regularly changing group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Periprosthetic infection rate	Incidence of patients to be diagnosed with periprosthetic infection according to MSIS criteria.	90 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants who agreed to inclusion in the study

Exclusion Criteria:

Missing follow-up
Participants with insufficient data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Orkhan Aliyev, MD	Contact	+905059917419		orkhanaliyev@outlook.com.tr

Overall Officials

Name	Affiliation	Role
Orkhan Aliyev, MD	Bezmialem Vakif University	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17403800	Background	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.
31188156	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.

ID	Term
D007239	Infections
D013530	Surgical Wound Infection
D014946	Wound Infection

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms