LocalVancomycinPowderToPreventPeriprostheticJointInfection.

Phase 2

Not yet recruiting

• Conditions: Arthroplasty Complications; Periprosthetic Fracture of Hip
• Interventions: Drug: Vancomycin; Procedure: Total knee or total hip arthroplasty

• Registration Number: NCT05697965
• Lead Sponsor: Assiut University

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 .

Study Timeline

• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2023-01-15
• Study First Posted: 2023-01-26
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-10
• Study Start: 2023-03-01
• Primary Completion: 2024-05
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Vancomycin loaded group	Vancomycin	applying 1 gm of vancomycin powder intracapsularly during primary total knee and hip arthroplasty operations
Vancomycin loaded group	Total knee or total hip arthroplasty	applying 1 gm of vancomycin powder intracapsularly during primary total knee and hip arthroplasty operations
Non vancomycin loaded group	Total knee or total hip arthroplasty	Total knee \& hip arthroplasty done without applying local vancomycin powder comparing the results with vancomycin loaded group

Primary Outcome Measures

Name	Time	Method
Follow up for infected patients after 90 days with surgical site infection.	3 months after operation	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

Name	Time	Method
Aseptic wound complications such as skin erosion, wound dehiscence, and prolonged wound healing.	3 months	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.