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Infection Rates Between Using of Vancomycin Versus Gentamycin in Primary ACLR

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06050785
Collaborator
(none)
110
Enrollment
4
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of the study is to compare the efficacy of Vancomycin versus Gentamycin , in reducing infection rates following Anterior Cruciate Ligament Reconstruction .

Condition or Disease Intervention/Treatment Phase

Detailed Description

There has been a marked increase in the number of cases of anterior cruciate ligament reconstruction (ACLR) worldwide. ACLR helps in the restoration of knee instability. But infection following ACLR is a big complication(1) .It may require multiple reoperations in the form of irrigation and debridement, prolonged use of antibiotics, removal of the graft, and sometimes graft revision surgery. It also has increases the risk of early osteoarthritis, and causes graft failure (2,3) .

There are a number of contributing factors that can lead to infection, like the presence of comorbid conditions like diabetes or concomitant open surgical procedures, Use of larger incisions, longer tourniquet time, and use of drain are other contributing factors(4) .Some studies have reported increased chances of infection with hamstring autografts in comparison to patellar tendon autografts and drain application(5,6). The harvested graft is prone to infection from skin flora, and an adequate concentration of antibiotics to inhibit bacterial growth can be achieved with the local application of antibiotics over the graft(7) .The most common pathogen after ACLR is staphylococci, accounting for 90% of cases of septic arthritis (8,9).

Vancomycin is commonly used locally in the surgery in Orthopaedics because of the relative safety for local use in high dosis, and bactericidal action against organisms like Staphylococcus aureus (10) on the other hand there are concerns about its use because of antibiotic resistance, high cost, and graft toxicity(11) . Several studies evaluated the effect of gentamicin solution on ACLR(7). Gentamycin offers an advantage in terms of activity against staphylococci, Gram-negative pathogens, and pseudomonas, along with being cost-effective(7).

The objective of the present study is to compare the infection rate with pre-soaking of harvested grafts in Vancomycin vesus Gentamycin during ACLR.

Study Design

Study Type:
Observational
Anticipated Enrollment :
110 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of Infection Rate Between Vancomycin and Gentamycin for Intraoperative Presoaking of Graft in Primary Anterior Cruciate Ligament Reconstruction ( Randomized Controlled Trial )
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Vancomycin group

Drug: Vancomycin
ACL graft will be soaked in vancomycin versus gentamycin
Other Names:
  • Gentamycin

    		•
    Gentamycin group

    Drug: Vancomycin
    ACL graft will be soaked in vancomycin versus gentamycin
    Other Names:
  • Gentamycin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assessment the infection rates between using the Vancomycin versus Gentamycin [1-10-2023 to 1-10-2024]

    Secondary Outcome Measures

    1. Functional outcome and recurrence rate after ACL reconstruction after the use of different antibiotics . Rerupture rate [1-10-2023 to 1-10-2024]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
      1. any patient for ACLR
    Exclusion Criteria:
      1. Revision ACL surgery 2) Previous Knee Surgery 3) Associated knee operations other than meniscal surgery (eg.HTO) 4) Open ACL reconstruction 5) Immune suppressed patients (eg. diabetic and patients taking steroids )

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mina Anwer Tawfek, Doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT06050785
    Other Study ID Numbers:
    • ACLR
    First Posted:
    Sep 22, 2023
    Last Update Posted:
    Sep 22, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Anterior Cruciate Ligament Injuries
    Vancomycin
    Gentamicins

    Study Results

    No Results Posted as of Sep 22, 2023