LocalVancomycinPowderToPreventPeriprostheticJointInfection.

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05697965
Study type	Interventional
Source	Assiut University
Contact	Maro Boktor, Master
Phone	+01023454251
Email	marombb54@gmail.com
Status	Not yet recruiting
Phase	Phase 2
Start date	March 1, 2023
Completion date	August 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.