Comparing two methods to prevent infection in ACL reconstruction surgery
Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in Decreasing the Risk of Infection in ACL Reconstruction Surgery: A Randomized Controlled Trial
NA · University of Duhok · NCT06166381
This study is testing whether using grafts soaked in vancomycin can better prevent infections after ACL surgery compared to regular antibiotics for patients aged 20 to 45.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 288 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | All |
| Sponsor | University of Duhok (other) |
| Locations | 1 site (Duhok) |
| Trial ID | NCT06166381 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of vancomycin-soaked autografts versus standard parenteral antibiotics in preventing infections following anterior cruciate ligament (ACL) reconstruction surgery. Patients aged 20 to 45 with ACL dysfunction will be randomly assigned to receive either standard antibiotics or antibiotics combined with vancomycin-soaked grafts. The study will assess the occurrence of post-operative infections to determine if the vancomycin-soaked method significantly reduces infection rates compared to the control group. Conducted at Azadi Teaching Hospital in Duhok, Iraq, this trial seeks to improve surgical outcomes for ACL reconstruction patients.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 20 to 45 with ACL injuries that affect their daily activities or sports.
Not a fit: Patients requiring revision ACL surgery or those with inflammatory rheumatological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of post-operative infections in patients undergoing ACL reconstruction.
How similar studies have performed: While the use of antibiotics in surgical procedures is common, the specific approach of using vancomycin-soaked grafts is novel and has not been extensively tested in ACL reconstruction.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ACL injury that interferes with life activities and/or sports Exclusion Criteria: * Patients for revision surgery of ACL reconstruction * patients with inflammatory rheumatological disorders * Refusal to participate in the study.
Where this trial is running
Duhok
- College of Medicine/University of Duhok — Duhok, Iraq (RECRUITING)
Study contacts
- Study coordinator: Jagar O Doski
- Email: jager.doski@uod.ac
- Phone: 07504594137
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infection, Bacterial, Anterior cruciate ligament, reconstruction, infection, vancomycin presoaked graft