NCT05697965

LocalVancomycinPowderToPreventPeriprostheticJointInfection.

TheUseofLocalVancomycinPowdertoPreventPeriprostheticJointInfectioninPrimaryTotalHipandKneeArthroplasty.ARandomizedControlledTrial.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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 .

Conditions

• Arthroplasty Complications
• Periprosthetic Fracture of Hip

Interventions

Type	Name	Description
DRUG	Vancomycin	applying 1 gm of vancomycin powder intracapsularly during primary total knee and hip arthroplasty to prevent periprosthetic joint infection
PROCEDURE	Total knee or total hip arthroplasty	Primary total knee or total hip arthroplasty without using local vancomycin

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-05-01
• Completion: 2024-08-01
• First posted: 2023-01-26
• Last updated: 2023-02-10