Anterior Cruciate Ligament InjuriesACLRNCT06050785
Infection Rates Between Using of Vancomycin Versus Gentamycin in Primary ACLR
An observational study of Anterior Cruciate Ligament Injuries, run by Assiut University.
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 . Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Vancomycin
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Any patient admitted to Assiut University hospital
Who may be able to join
- 1) any patient for ACLR
Who cannot join
- 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 )
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Infection Rate Between Vancomycin and Gentamycin for Intraoperative Presoaking of Graft in Primary Anterior Cruciate Ligament Reconstruction ( Randomized Controlled Trial )
The purpose of the study is to compare the efficacy of Vancomycin versus Gentamycin , in reducing infection rates following Anterior Cruciate Ligament Reconstruction .
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Vancomycin
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Also called Gentamycin
ACL graft will be soaked in vancomycin versus gentamycin
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin group | Not described Receives: Drug: Vancomycin | |
| Gentamycin group | Not described Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment the infection rates between using the Vancomycin versus Gentamycin
Measured: 1-10-2023 to 1-10-2024
Secondary outcomes (1)
Functional outcome and recurrence rate after ACL reconstruction after the use of different antibiotics . Rerupture rate
Measured: 1-10-2023 to 1-10-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Feb 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Anwer Tawfek, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050785
- Sponsor's protocol ID
- ACLR
- Acronym
- ACLR
- Status last verified
- Feb 2024
- First submitted
- 16 Sep 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Infection Rate Between Vancomycin and Gentamycin for Intraoperative Presoaking of Graft in Primary Anterior Cruciate Ligament Reconstruction ( Randomized Controlled Trial )
- ClinicalTrials.gov ID
- NCT06050785
- Acronym / sponsor ID
- ACLR / ACLR
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin group | – | Drug: Vancomycin |
| Gentamycin group | – | Drug: Vancomycin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient admitted to Assiut University hospital
Key inclusion criteria (1 listed)
- 1) any patient for ACLR
Key exclusion criteria (1 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VancomycinAlso: GentamycinACL graft will be soaked in vancomycin versus gentamycin | Drug | Gentamycin group, Vancomycin group |
Primary outcome
Assessment the infection rates between using the Vancomycin versus Gentamycin
Time frame: 1-10-2023 to 1-10-2024
1 secondary outcome
Functional outcome and recurrence rate after ACL reconstruction after the use of different antibiotics . Rerupture rate
Time frame: 1-10-2023 to 1-10-2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injuries, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mina Anwer (01221125082, Minaanwer100@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment the infection rates between using the Vancomycin versus Gentamycin (time frame: 1-10-2023 to 1-10-2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.