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NCT Number: NCT06166381

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

An anterior cruciate ligament (ACL) tear is one of the knee joint's most common soft tissue injuries [1]. It is frequently injured in non-contact and some contact competition sports and even during ordinary life activities. With an annual incidence of 68.6 per 100,000 person-years, ACL tears remain a common orthopedic injury [2]. Females are two to eight times more likely to develop ACL tears in sports compared to men who play the same particular sports [3]. Most highly demanding persons and those who develop frequent instability of their knee require reconstructive surgery on the ACL to prevent early degenerative changes in their knees. This is done by completely removing the torn or ruptured ACL and replacement with a piece of tendon or ligament (graft) [4].

Post-operative infection may occur in 0.14-2.6% of ACL reconstruction despite intravenous antibiotics prophylaxis [5,6]. The deep infection results in poor outcomes with pain, stiffness, arthrofibrosis, and articular cartilage degeneration [7,8]. Few studies reported improved outcomes of infection control when the autograft presoaked in vancomycin solution during the preparation process outside the body before being transferred to the knee of the patient [9-13]. Systematic reviews and meta-analysis showed that all the articles discussing the outcome of vancomycin presoaked autograft in ACL reconstruction surgery were case series, observational retrospective, prospective comparative, or case-control studies [14,15]. Randomized control trial (RCT) provides the strongest evidence among the primary research studies to confirm the effectiveness of a new method of treatment [16,17]. To date, there is no available RCT study in this field.

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Key information

Conditions

Infection, Bacterial Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Aim This study aims to do RTC research on the role of vancomycin-presoaked autograft in ACL reconstruction to decrease the risk of infection.

Objectives To treat patients undergoing ACL reconstruction surgery by two methods to prevent infection (parenteral antibiotic and combined parenteral antibiotic with vancomycin presoaked autograft). To compare between odds ratio of infection occurrence. To check the superiority of the added vancomycin presoaked method in decreasing the risk of infection.

Methods Study type It will be a randomized controlled clinical trial of superiority type. It will be based on a parallel-group type with an allocation ratio of 1:1.

Study setting The research will be conducted in the orthopedic unit, at Azadi Teaching Hospital, Duhok, Iraq.

Inclusion criteria

Patients between the ages of 20 to 45 years, of any sex, with ACL dysfunction and needing ACL reconstruction surgery, will be involved in this research.

Exclusion criteria

Patients for revision surgery of ACL reconstruction, inflammatory rheumatological disorders, and refusal to participate in the study.

Interventions The patients will be divided into 2 groups: group one (control) will be those who will receive only parenteral antibiotics at induction of anesthesia and for 5 days after the operation. The second group (trial) will receive parenteral antibiotics combined with soaking the autograft of ACL autograft into the vancomycin solution duration preparation of the graft recipient site.

Outcomes The primary outcome will be the odds of cases developing signs of infection up to 6 months postoperatively. No secondary outcome will be recorded for this study.

Sample size The assumed sample size was calculated by using the G*Power 3.1.9.7 computer software program. A minimum of 288 participants (144 for each group) are required to have an 80% chance of detecting the difference between the groups with a two-sided 95% confidence level (0.05 level of significance) to achieve a difference in the odds ratio of 1.8.

Randomization

The allocation of the participants into the modalities of the treatment will be done by a simple randomization method with an allocation ratio of 1:1. It will be generated by using the website program www.randomization.com.

Statistical analysis The data analysis will be performed by SPSS 23.0. The statistical analysis will include the standard descriptive statistics used to describe the basic descriptive data of the patients. The means and standard deviations (SD) or medians and interquartile ranges were used for the continuous variables, while frequencies and percentages were used for the categorical variables. The comparison between the outcomes of the treatment modalities in both groups will be done by finding the difference between the summary statistics in the Chi-squared test. The difference will be considered statistically significant when the p-value is less than 0.05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parenteral Antibacterial Agents

Drug

Parenteral antibiotic (ceftriaxone) 1 g to be given in 3 doses, at induction of anesthesia, 12 hours postoperative, and 24 hours postoperative.

Other names: Ceftriaxone sodium

Parenteral Antibacterial Agents plus Vancomycin pre-soaked graft

Drug

in addition to the parenteral ceftriaxone intravenous injections, the ACL graft will be soaked in the vancomycin solution for 20 minutes when prepared outside the body of patient.

Other names: Ceftriaxone sodium intravenously plus Vancomycin pre-soaked graft

Primary outcomes

  1. infection

    Time frame: 1st day postoperative upto 6 months

    deep infection occurs around the graft of the ACL

Study contacts

Contact information is provided by the study sponsor or research team.

Jagar O Doski

CONTACT

[email protected]

07504594137

Sponsors and collaborators

Lead sponsor

University of Duhok

Other

Registry information

Official study title

Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in Decreasing the Risk of Infection in ACL Reconstruction Surgery: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 12, 2023
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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