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

January 13, 2024 updated by: Jagar Omar Doski, University of Duhok

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

288

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control
This group will receive parenteral antibiotics to prevent infection in the surgery.
Drug: Parenteral Antibacterial Agents
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
Experimental: clinical trial
This group will include patients who will receive parenteral antibiotics combined with vancomycin presoaked solution for the graft.
Drug: Parenteral Antibacterial Agents
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
Drug: Parenteral Antibacterial Agents plus Vancomycin pre-soaked graft
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
infection
Time Frame: 1st day postoperative upto 6 months
deep infection occurs around the graft of the ACL
1st day postoperative upto 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Duhok

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 25, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 12, 2023

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 13, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123456789

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The information will be supplied to other researches on reasonable request.

IPD Sharing Time Frame

from the time of publication of the article and up to 5 years after.

IPD Sharing Access Criteria

email request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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