LocalVancomycinPowderToPreventPeriprostheticJointInfection.

Assiut University

Status and phase: Not yet enrolling; Phase 2

Conditions: Periprosthetic Fracture of Hip; Arthroplasty Complications

Treatments: Procedure: Total knee or total hip arthroplasty; Drug: Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT05697965

Vancomycin in Arthroplasty

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 174 estimated patients

Sex: All

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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174 participants in 2 patient groups

Vancomycin loaded group

Experimental group

Description:

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

Treatment:

Drug: Vancomycin

Procedure: Total knee or total hip arthroplasty

Non vancomycin loaded group

Experimental group

Description:

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

Treatment:

Procedure: Total knee or total hip arthroplasty