LocalVancomycinPowderToPreventPeriprostheticJointInfection.

NCT ID: NCT05697965

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-08-31

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 .

Conditions

Arthroplasty Complications; Periprosthetic Fracture of Hip

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Vancomycin loaded group

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

Group Type: EXPERIMENTAL

Vancomycin

Intervention Type: DRUG

applying 1 gm of vancomycin powder intracapsularly during primary total knee and hip arthroplasty to prevent periprosthetic joint infection

Total knee or total hip arthroplasty

Intervention Type: PROCEDURE

Primary total knee or total hip arthroplasty without using local vancomycin

Non vancomycin loaded group

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

Group Type: EXPERIMENTAL

Total knee or total hip arthroplasty

Intervention Type: PROCEDURE

Primary total knee or total hip arthroplasty without using local vancomycin

Interventions

Vancomycin

applying 1 gm of vancomycin powder intracapsularly during primary total knee and hip arthroplasty to prevent periprosthetic joint infection

Intervention Type: DRUG

Total knee or total hip arthroplasty

Primary total knee or total hip arthroplasty without using local vancomycin

Intervention Type: PROCEDURE

Other Intervention Names

Vancomycin sulphate

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Maro Maher Botros Boktor

Resident physician at Orthopedic& Trauma department,principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yossef Saleh

Role: PRINCIPAL_INVESTIGATOR

Vice president

Central Contacts

Maro Boktor, Master

Role: CONTACT

marombb54@gmail.com

+01023454251

Mohammad AbdelNasser

Role: CONTACT

Abdelnasser.m.k@aun.edu.eg

01002438664

References

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.

Reference Type: BACKGROUND

PMID: 25967254 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22554729 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21304438 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24745317 (View on PubMed)

Other Identifiers

Vancomycin in Arthroplasty

Identifier Type: -

Identifier Source: org_study_id