NCT05697965

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
174

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2023

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

1.2 years

First QC Date

July 12, 2022

Last Update Submit

February 9, 2023

Conditions

Arthroplasty ComplicationsPeriprosthetic Fracture of Hip

Outcome Measures

Primary Outcomes (1)

  • Follow up for infected patients after 90 days with surgical site infection.

    The purpose of this study is evaluation of the efficacy and complication profile of local vancomycin application in primary arthroplasty. 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 that will be evaluated by inflammatory markers CRP (if more than 1 gm/dl), ESR(more than 20) as laboratory investigations.

    3 months after operation

Secondary Outcomes (1)

  • Aseptic wound complications such as skin erosion, wound dehiscence, and prolonged wound healing.

    3 months

Study Arms (2)

Vancomycin loaded group

EXPERIMENTAL

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

Drug: VancomycinProcedure: Total knee or total hip arthroplasty

Non vancomycin loaded group

EXPERIMENTAL

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

Procedure: Total knee or total hip arthroplasty

Interventions

VancomycinDRUG

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

Also known as: Vancomycin sulphate
Vancomycin loaded group
Total knee or total hip arthroplastyPROCEDURE

Primary total knee or total hip arthroplasty without using local vancomycin

Non vancomycin loaded groupVancomycin loaded group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all patients population who will undergo primary total knee or total hip arthroplasty

You may not qualify if:

  • patients with diabetes mellitus inflammatory arthritis diseases smokers BMI \> 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 25967254BACKGROUND

  • 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.

    PMID: 22554729BACKGROUND

  • 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.

    PMID: 21304438BACKGROUND

  • 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.

    PMID: 24745317BACKGROUND

MeSH Terms

Interventions

VancomycinArthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsArthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Yossef Saleh

    Vice president

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maro Boktor, Master

CONTACT

+01023454251marombb54@gmail.com

Mohammad AbdelNasser

CONTACT

01002438664Abdelnasser.m.k@aun.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident physician at Orthopedic& Trauma department,principal investigator

Study Record Dates

First Submitted

July 12, 2022

First Posted

January 26, 2023

Study Start

March 1, 2023

Primary Completion

May 1, 2024

Study Completion

August 1, 2024

Last Updated

February 10, 2023

Record last verified: 2023-02