Infection Rates Between Using of Vancomycin Versus Gentamycin in Primary ACLR

Not yet recruiting

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Drug: Vancomycin

• Registration Number: NCT06050785
• Lead Sponsor: Assiut University

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 .

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 Timeline

• Study First Submitted: 2023-09-16
• Study First Submitted QC: 2023-09-16
• Study First Posted: 2023-09-22
• Status Verified: 2024-02
• Study Start: 2024-02-01
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05
• Primary Completion: 2025-01-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

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 )

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gentamycin group	Vancomycin	-
Vancomycin group	Vancomycin	-

Primary Outcome Measures

Name	Time	Method
Assessment the infection rates between using the Vancomycin versus Gentamycin	1-10-2023 to 1-10-2024

Secondary Outcome Measures

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