Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06050785 |
| Other study ID # |
ACLR |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2024 |
| Est. completion date |
February 1, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Assiut University |
| Contact |
Mina Anwer |
| Phone |
01221125082 |
| Email |
Minaanwer100[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of the study is to compare the efficacy of Vancomycin versus Gentamycin , in
reducing infection rates following Anterior Cruciate Ligament Reconstruction .
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.
