Actively Recruiting

Phase Not Applicable
Age: 20Years - 45Years
All Genders
ID06166381

Parenteral Antibiotics Versus Combined Parenteral Antibiotics and Vancomycin-Soaked Graft in Reducing Infection Risk After ACL Reconstruction Surgery: A Randomized Controlled Trial

Led by University of Duhok · Updated on 2024-12-30

288

Participants Needed

1

Research Sites

53 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Anterior cruciate ligament (ACL) tears are common knee injuries often caused by sports or daily activities. Females have a higher risk of ACL tears compared to males in similar sports. Surgery to reconstruct the ACL is needed for those with frequent knee instability or high physical demands to prevent early knee damage. Postoperative infections after ACL reconstruction occur in a small percentage of cases and can lead to pain, stiffness, and cartilage damage. Some studies suggest soaking the ACL graft in vancomycin before surgery may reduce infection risk, but no randomized controlled trials have confirmed this yet. This trial compares two approaches in ACL reconstruction surgery to prevent infection: one group receives parenteral antibiotic injections alone, and the other group receives the same antibiotics plus an ACL graft soaked in vancomycin for 20 minutes before implantation. The parenteral antibiotic ceftriaxone is given in three doses around the time of surgery. The study uses a randomized controlled design with equal allocation to each group. Participants aged 20 to 45 years with ACL injury needing reconstruction will be monitored for infection signs for up to six months after surgery. Researchers will collect data on infection occurrence to compare the effectiveness of the treatments. The study will be conducted at Azadi Teaching Hospital in Iraq and includes detailed statistical analysis to evaluate the results. The trial aims to enroll at least 288 participants to detect meaningful differences between the two treatment methods.

CONDITIONS

Official Title

Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in ACL Reconstruction

Who Can Participate

Age: 20Years - 45Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ACL injury that interferes with life activities and/or sports
Not Eligible

You will not qualify if you...

  • Previous ACL reconstruction surgery (revision surgery)
  • Having inflammatory rheumatological disorders
  • Refusal to participate in the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

College of Medicine/University of Duhok

Duhok, Iraq, 42001

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Research Team

J

Jagar O Doski

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Incidence of postoperative anterior cruciate ligament reconstruction infections: graft choice makes a difference.

Gregory B Maletis, Maria C S Inacio, Sarah Reynolds...

https://pubmed.ncbi.nlm.nih.gov/23749343

A surgical technique using presoaked vancomycin hamstring grafts to decrease the risk of infection after anterior cruciate ligament reconstruction.

Christopher J Vertullo, Mark Quick, Andrew Jones...

https://pubmed.ncbi.nlm.nih.gov/22112612

Autograft soaking in vancomycin reduces the risk of infection after anterior cruciate ligament reconstruction.

Daniel Pérez-Prieto, Raúl Torres-Claramunt, Pablo E Gelber...

https://pubmed.ncbi.nlm.nih.gov/25416672

No infections in 1300 anterior cruciate ligament reconstructions with vancomycin pre-soaking of hamstring grafts.

Michael Phegan, Jane E Grayson, Christopher J Vertullo

https://pubmed.ncbi.nlm.nih.gov/25771788