Clinical trial NCT05697965: LocalVancomycinPowderToPreventPeriprostheticJointInfection.
Official title: TheUseofLocalVancomycinPowdertoPreventPeriprostheticJointInfectioninPrimaryTotalHipandKneeArthroplasty.ARandomizedControlledTrial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Arthroplasty Complications
Periprosthetic Fracture of Hip
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 174
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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 .

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

Primary outcomes:
measure: Follow up for infected patients after 90 days with surgical site infection.
timeFrame: 3 months after operation
Secondary outcomes:
measure: Aseptic wound complications such as skin erosion, wound dehiscence, and prolonged wound healing.
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Vice president
name: Yossef Saleh
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.