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临床试验/NCT06368102
NCT06368102已完成4 期

Prophylactic Effects of Different Duration of Intravenous Ampicillin for Preventing Surgical Site Infection in Third Molar Surgery: a Randomized Controlled Trial

Uji Takeda Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年5月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Occurrence of surgical site infection

研究概览

简要总结

The purpose of this study is to determine the incidence of surgical site infection (SSIs) after third molar surgery for different duration of intravenous ampicillin administration.

详细描述

In recent years, the increase in drug-resistant bacteria and associated infections has become one of the major issues in the international community as adverse events associated with the inappropriate use of antimicrobial agents. Although the frequency and percentage of inappropriate use is currently unknown, it has been shown that at least 30% of antimicrobials prescribed in the U.S. are inappropriately used. If no action is taken against inappropriate antimicrobial use, it is estimated that 10 million people will die annually worldwide from drug-resistant organisms by 2050, with an estimated 4.9 million deaths related to drug-resistant organisms and 1.2 million deaths due to drug-resistant organisms already estimated for 2019. In addition, while the development of new antimicrobial agents has declined since the 1980s, the threat of new drug-resistant organisms, especially in hospitals, has increased, and if antimicrobial agents are not used appropriately, there is concern that there will be no effective antimicrobial agents available to treat infections in the future. It is important to avoid such situations by using antimicrobial agents, which are a limited resource, appropriately at this stage, and appropriate use of antimicrobial agents is necessary to prevent drug resistance (Antimicrobial Resistance: AMR).

Third molar extraction is the most commonly performed procedure in oral and maxillofacial surgery. One of the main complications after third molar extractions is surgical site infection (SSIs), which is reported to manifest as swelling, pain, abscess, and fever. According to a Cochrane review of randomized controlled trials, the risk of SSIs after third molar extraction in physically fit young patients is about 10%, but in patients with low immunity before extraction, the risk increases up to 25%. Prophylactic administration of antimicrobial agents has an important role in preventing SSIs. However, the efficacy of antimicrobial prophylaxis against SSIs in third molar extractions is controversial. While some studies have reported that antimicrobials are effective in preventing SSIs after third molar extraction, others have reported that they are not.

Guidelines for third molar extraction vary widely in the duration of antimicrobial administration (e.g., Japanese guidelines state a single dose to within 48 hours). In clinical practice, the final decision lies with the surgeon, but this difference in dosing period is a source of confusion. If the duration of administration could be shortened without increasing SSIs, it would contribute to the current presentation of AMR. Therefore, the purpose of this study is to examine the effect of different durations and doses of penicillins, which are considered first-line drugs after third molar surgery, on the prevention of SSIs.

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
None

入排标准

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

入选标准

  • Minimum age of 20 years
  • American Society of Anesthesiologists (ASA) physical status of 1
  • Planned extraction of bilateral mandibular third molar with the necessity of bone removal based on panoramic radiography in an inpatient setting under IV sedation
  • Agreement to follow the study protocol

排除标准

  • Pregnancy or suspicion of pregnancy
  • Allergy and/or contraindication to ampicillin
  • History of a known SSI risk factors, such as diabetes, steroid or immunosuppressant use, and endocarditis
  • Receiving any antibiotic therapy
  • Active infection of the third molars with pus, edema, and trismus

研究组 & 干预措施

1day-group

Experimental

Participants will receive 1g of IV ampicillin before surgery and 1 time after surgery on the day of surgery (total 2g)

干预措施: Ampicillin (Drug)

2day-group

Experimental

Participants will receive 1g of IV ampicillin before surgery and 2 times after surgery up to the next day (total 3g)

干预措施: Ampicillin (Drug)

结局指标

主要结局

Occurrence of surgical site infection

时间窗: 30 days

is evaluated based on the guidelines by the Center for Disease Control and Prevention (CDC) and Clavien-Dindo classification system: within 30 days postoperatively, drainage from a surgical wound or abscess, requiring treatment with antimicrobial agents.

次要结局

  • Occurrence of alveolar osteitis(7 days)

研究者

发起方
Uji Takeda Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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