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
About this trial
This is an interventional prevention trial for Arthroplasty Complications
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
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
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
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