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LocalVancomycinPowderToPreventPeriprostheticJointInfection.

Primary Purpose

Arthroplasty Complications, Periprosthetic Fracture of Hip

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Vancomycin
Total knee or total hip arthroplasty
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arthroplasty Complications

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: all patients population who will undergo primary total knee or total hip arthroplasty Exclusion Criteria: patients with diabetes mellitus inflammatory arthritis diseases smokers BMI > 40

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Vancomycin loaded group

    Non vancomycin loaded group

    Arm Description

    applying 1 gm of vancomycin powder intracapsularly during primary total knee and hip arthroplasty operations

    Total knee & hip arthroplasty done without applying local vancomycin powder comparing the results with vancomycin loaded group

    Outcomes

    Primary Outcome Measures

    Follow up for infected patients after 90 days with surgical site infection.
    The purpose of this study is evaluation of the efficacy and complication profile of local vancomycin application in primary arthroplasty. The use of local antibiotics would decrease the rate of infection compared to controls and this will be achieved by applying 1 gm of vancomycin powder intracapsularly that will be evaluated by inflammatory markers CRP (if more than 1 gm/dl), ESR(more than 20) as laboratory investigations.

    Secondary Outcome Measures

    Aseptic wound complications such as skin erosion, wound dehiscence, and prolonged wound healing.
    The purpose of this study is evaluation of the efficacy and complication profile of local vancomycin application in primary arthroplasty. The investigators hypothesized that the use of local antibiotics would decrease the rate of infection compared to controls and this will be achieved by applying 1 gm of vancomycin powder intracapsularly by examination wound site if there's surgical site infection, dehescience, abscess, discharge.

    Full Information

    First Posted
    July 12, 2022
    Last Updated
    February 9, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05697965
    Brief Title
    LocalVancomycinPowderToPreventPeriprostheticJointInfection.
    Official Title
    TheUseofLocalVancomycinPowdertoPreventPeriprostheticJointInfectioninPrimaryTotalHipandKneeArthroplasty.ARandomizedControlledTrial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    May 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy and complication profile of local vancomycin application in primary arthroplasty. The investigators hypothesized that the use of local antibiotics would decrease the rate of infection compared to controls and this will be achieved by applying 1 gm of vancomycin powder intracapsularly.
    Detailed Description
    Periprosthetic joint infection is a truly devastating complication of total joint arthroplasty (TJA), causing most patients to undergo a revision surgery and to bear significant psychological and financial burden. Surveys suggest patients of total joint arthroplasty undergoing revision for infection have poorer functional outcomes and satisfaction levels than patients undergoing revision for other reasons, with negative consequences being more persistent . Despite developments in infection prophylaxis and risk factor mitigation, patients with periprosthetic joint infection represent a substantial societal and monetary cost to our value-based health care system. Thus, there is significant interest in developing and systematically evaluating new PJI prophylaxis measures to reduce this rate. Historically, local wound vancomycin powder has been shown to safely reduce infection rates in spine surgery. The earliest and strongest support for local vancomycin powder for primary orthopedic surgery came from the spine literature, and it now has support in the shoulder and elbow and foot and ankle literature. The use of topical vancomycin was first reported in 1989 when the application of topical vancomycin to the sternum in cardio thoracic patients reduced rates of sternal infection from 3.6% to 0.45%). Similarly, multiple studies have shown that vancomycin decreases the rate of postoperative infections in patients undergoing spinal surgery. Importantly, data on topical vancomycin powder used alone remain inconclusive for TJA, with some stating that it may increase aseptic wound complications, and others stating that it reduces PJI significantly .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthroplasty Complications, Periprosthetic Fracture of Hip

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Factorial Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    174 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vancomycin loaded group
    Arm Type
    Experimental
    Arm Description
    applying 1 gm of vancomycin powder intracapsularly during primary total knee and hip arthroplasty operations
    Arm Title
    Non vancomycin loaded group
    Arm Type
    Experimental
    Arm Description
    Total knee & hip arthroplasty done without applying local vancomycin powder comparing the results with vancomycin loaded group
    Intervention Type
    Drug
    Intervention Name(s)
    Vancomycin
    Other Intervention Name(s)
    Vancomycin sulphate
    Intervention Description
    applying 1 gm of vancomycin powder intracapsularly during primary total knee and hip arthroplasty to prevent periprosthetic joint infection
    Intervention Type
    Procedure
    Intervention Name(s)
    Total knee or total hip arthroplasty
    Intervention Description
    Primary total knee or total hip arthroplasty without using local vancomycin
    Primary Outcome Measure Information:
    Title
    Follow up for infected patients after 90 days with surgical site infection.
    Description
    The purpose of this study is evaluation of the efficacy and complication profile of local vancomycin application in primary arthroplasty. The use of local antibiotics would decrease the rate of infection compared to controls and this will be achieved by applying 1 gm of vancomycin powder intracapsularly that will be evaluated by inflammatory markers CRP (if more than 1 gm/dl), ESR(more than 20) as laboratory investigations.
    Time Frame
    3 months after operation
    Secondary Outcome Measure Information:
    Title
    Aseptic wound complications such as skin erosion, wound dehiscence, and prolonged wound healing.
    Description
    The purpose of this study is evaluation of the efficacy and complication profile of local vancomycin application in primary arthroplasty. The investigators hypothesized that the use of local antibiotics would decrease the rate of infection compared to controls and this will be achieved by applying 1 gm of vancomycin powder intracapsularly by examination wound site if there's surgical site infection, dehescience, abscess, discharge.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: all patients population who will undergo primary total knee or total hip arthroplasty Exclusion Criteria: patients with diabetes mellitus inflammatory arthritis diseases smokers BMI > 40
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maro Boktor, Master
    Phone
    +01023454251
    Email
    marombb54@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammad AbdelNasser
    Phone
    01002438664
    Email
    Abdelnasser.m.k@aun.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yossef Saleh
    Organizational Affiliation
    Vice president
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25967254
    Citation
    Wukich DK, Dikis JW, Monaco SJ, Strannigan K, Suder NC, Rosario BL. Topically Applied Vancomycin Powder Reduces the Rate of Surgical Site Infection in Diabetic Patients Undergoing Foot and Ankle Surgery. Foot Ankle Int. 2015 Sep;36(9):1017-24. doi: 10.1177/1071100715586567. Epub 2015 May 12.
    Results Reference
    background
    PubMed Identifier
    22554729
    Citation
    Kurtz SM, Lau E, Watson H, Schmier JK, Parvizi J. Economic burden of periprosthetic joint infection in the United States. J Arthroplasty. 2012 Sep;27(8 Suppl):61-5.e1. doi: 10.1016/j.arth.2012.02.022. Epub 2012 May 2.
    Results Reference
    background
    PubMed Identifier
    21304438
    Citation
    Sweet FA, Roh M, Sliva C. Intrawound application of vancomycin for prophylaxis in instrumented thoracolumbar fusions: efficacy, drug levels, and patient outcomes. Spine (Phila Pa 1976). 2011 Nov 15;36(24):2084-8. doi: 10.1097/BRS.0b013e3181ff2cb1.
    Results Reference
    background
    PubMed Identifier
    24745317
    Citation
    Yan H, He J, Chen S, Yu S, Fan C. Intrawound application of vancomycin reduces wound infection after open release of post-traumatic stiff elbows: a retrospective comparative study. J Shoulder Elbow Surg. 2014 May;23(5):686-92. doi: 10.1016/j.jse.2014.01.049.
    Results Reference
    background

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