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临床试验/NCT06166381
NCT06166381招募中不适用

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

University of Duhok1 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2024年1月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
288
试验地点
1
主要终点
infection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ACL injury that interferes with life activities and/or sports

排除标准

  • Patients for revision surgery of ACL reconstruction
  • patients with inflammatory rheumatological disorders
  • Refusal to participate in the study.

研究组 & 干预措施

control

Active Comparator

This group will receive parenteral antibiotics to prevent infection in the surgery.

干预措施: Parenteral Antibacterial Agents (Drug)

clinical trial

Experimental

This group will include patients who will receive parenteral antibiotics combined with vancomycin presoaked solution for the graft.

干预措施: Parenteral Antibacterial Agents (Drug)

clinical trial

Experimental

This group will include patients who will receive parenteral antibiotics combined with vancomycin presoaked solution for the graft.

干预措施: Parenteral Antibacterial Agents plus Vancomycin pre-soaked graft (Drug)

结局指标

主要结局

infection

时间窗: 1st day postoperative upto 6 months

deep infection occurs around the graft of the ACL

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jagar Omar Doski

Assistant Professor

University of Duhok

研究点 (1)

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