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临床试验/NCT05398081
NCT05398081已完成2 期

Comparative Efficacy of Intravenous Cefuroxime and Ceftriaxone in Preventing Surgical Site Infection After Neurosurgical Procedures

Dr. Promise Tamunoipiriala Jaja1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2021年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
96
试验地点
1
主要终点
Types and number of organism(s) causing surgical site infection

研究概览

简要总结

BACKGROUND: Surgical site infection (SSI) is potentially catastrophic in neurosurgical procedures, causing poor in-hospital outcomes in more than half of those affected and significantly increased length of hospital stay. The appropriate and timely use of prophylactic antibiotics is found to reduce the prevalence of SSIs. At present, several regimen of antimicrobial agents are used in neurosurgical procedures since the choice of appropriate antibiotic agent is not fully established. Cephalosporins are among the frequently used antibiotics for prophylaxis in neurosurgical procedures, with studies comparing first and second generation Cephalosporins to third generation in neurosurgical prophylaxis, showing no superiority of the latter over the former. Clearly, comparing Cefuroxime (a second generation Cephalosporin) to Ceftriaxone (a third generation Cephalosporin) in neurosurgical procedures will provide more knowledge on the efficacy of Cefuroxime as antibiotics prophylaxis.

OBJECTIVE: The study aimed to determine the comparative efficacy of cefuroxime versus ceftriaxone in the prevention of surgical site infection after neurosurgical procedures at the University College Hospital Ibadan, Nigeria.

METHODS: The study will be a randomized controlled trial recruiting 92 participants. Participants would be patients undergoing neurosurgical procedures; they will be randomized to treatment arms (those receiving cefuroxime versus ceftriaxone for antibiotic prophylaxis). All the study articipants will be followed up for 30 days to assess for the development of surgical site infection.

DATA ANALYSIS: Data will be collated, computed and analyzed using the Statistical Product and Service Solutions (SPSS) Version 21. Demographics will be presented using summary statistics; mean +/- standard deviation and figures (e.g pie chart, histogram). Study outcomes will yield categorical and continuous variables which will be analyzed using chi-squared test and Z-test and/or T-test for hypothesis testing.

详细描述

BACKGROUND Surgical Site Infection (SSI) is the most common health care-associated infection in hospitalized patients, accounting for 31% of all infections globally.

The prevalence of SSI is determined by the antibiotics prophylaxis, the duration of postoperative monitoring, the institution and the type of surgical procedures. It ranges between 1% and 17% in most surgical specialties. In the Sub-Saharan Africa, the prevalence of SSI following neurosurgical procedures when two different third-generation cephalosporins were used as antibiotic prophylaxis in the same institution were 6.9% and 15% respectively. It is indeed catastrophic, causing poor in-hospital outcomes in upwards of half of those affected and significantly increased their length of hospital stay. SSI following craniotomy costs an average of ₤9,283 above the initial cost of treatment to manage, in addition to the prolonged disablement and reduced functioning of the patient.

Appropriate and timely use of prophylactic antibiotics reduced the prevalence of SSIs from 8.8% to 4.6%. At present, several regimen of antimicrobial agents are used in neurosurgical procedures in the absence of a 'choice' antibiotic agent. The choice, ideal antibiotics should have an appropriate antimicrobial spectrum and favourable pharmacokinetics.

Cephalosporin is among the frequently used antibiotics for prophylaxis in neurosurgical procedures due to its wide spectrum of their effectiveness, good tissue penetration, and the low toxicity of its first and second generation agents. They are bactericidal agents, with a beta-lactam ring structure that determines their antibacterial activity and a six-member dihydrothiazine ring which is responsible for their ability to resist inactivation by certain bacterial enzymes. They have different antibacterial activity based on substitutions at position 7 of the Cephalosporin nucleus. Following penetration of the bacterial cell surface, they attach to bacterial penicillin-binding proteins - proteins thay catalyze critical cell-wall synthesis and division reactions; thus interrupting of bacterial cell-wall synthesis and division.

The first and second-generation Cephalosporins also have the pharmacological advantage that in case of postoperative infection the third and other newer generation Cephalosporin can be given with only a slight chance of developing early resistance.Third generation Cephalosporins, due to their better coverage of gram-negative bacteria compared to the first and second generation agents, have somewhat been put forward since some noticeable change in spectrum toward more gram-negative bacteria has been observed in the microbiological profiles of some series on SSI. Mainly gram-positive cocci; (especially S.aureus and S.epidermidis) are associated with SSI in neurosurgery.

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
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients scheduled for clean and clean-contaminated neurosurgical procedures that consent to participating in the study.

排除标准

  • Patients with contaminated and dirty wounds e.g. grossly contaminated open depressed skull fracture, cranial endonasal surgeries and so on.
  • Patients who has had systemic antibiotic therapy within 7 days before surgery.
  • Patients with diabetes mellitus.
  • Patients with implants (they will need longer follow up).
  • Allergy to cephalosporins
  • Infectious disease such as brain abscess, subdural empyema, osteitis and scalp infection

研究组 & 干预措施

Cefuroxime

Experimental

Cefuroxime (Zinnat®) will be used as prophylactic antibiotic in this arm

干预措施: Cefuroxime (Zinnat®) (Drug)

Ceftriaxone

Active Comparator

Ceftriaxone (Rocephin®) will be used as prophylactic antibiotic in this arm

干预措施: Ceftriaxone (Rocephin®) (Drug)

结局指标

主要结局

Types and number of organism(s) causing surgical site infection

时间窗: Six weeks

The organisms isolated following culture of samples from an area of surgical site infection will be identified and a count will be made.

Surgical site infection

时间窗: Six weeks

The presence or absence surgical site infection

次要结局

  • Cost of care(Six weeks)

研究者

发起方
Dr. Promise Tamunoipiriala Jaja
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Promise Tamunoipiriala Jaja

Doctor

University College Hospital, Ibadan

研究点 (1)

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