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临床试验/NCT06527989
NCT06527989尚未招募2 期

Prophylactic Antibiotic in Subtalar Fusion Surgery: 24 Hours Versus 5 Days

Assiut University0 个研究点目标入组 102 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
尚未招募
入组人数
102
主要终点
assessment of incidence rate of surgical site infection

研究概览

简要总结

Assessment of surgical site infection when using postoperative antibiotic prophylaxis in subtalar fusion surgery 24hours versus 5 days

详细描述

Infection in orthopedic surgery is one of the most dreaded complications. Antibiotic prophylaxis should be utilized routinely in foot and ankle surgeries involving bone, utilizing hardware and prosthetic joints.

It is appropriate for the antibiotics to be administered within 60 minutes prior to surgery, discontinued within 24 hours after surgery, given prior to tourniquet inflation, and utilized routinely in prolonged foot and ankle surgery cases.

Narrow spectrum antibiotics covering Staphylococcus aureus should be utilized for prophylaxis in patients without a history of resistant infection. According to American Society of Health System Pharmacists (ASHP) cefazolin was the most used antibiotic in preoperative prophylaxis, combination of cefazolin with gentamicin was the second common regimen while 3rd generation cephalosporin were 3rd widely used antibiotics.

The controversy persists in administration of antibiotics varying from a single dose to 3 doses to 5 days or 14 days. In subtropical country, with a hot and humid climate is a conducive environment for both Gram-positive and Gram-negative bacterial colonization of skin. Therefore, we need studies tailored to our environment in Egypt Prevention of SSIs is critical for the health of patients, Economic efficiency, Antibiotic resistance considerations In conclusion, in many ways, the topic of prophylactic antibiotics in elective foot and ankle surgery is an unusual one, in that a relative divide exists between empirical science and common practice.

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • posttraumatic subtallar osteoarthritis
  • adult age 18 up to 60
  • good skin condition healthy

排除标准

  • comorbidities such as Diabetes Mellitus, Autoimmune diseases
  • previous foot surgery
  • wounds near surgical incision
  • skin infection

研究组 & 干预措施

ceftriaxone 2 grams

Experimental

Single dose 2grams of ceftriaxone in 1st 24 hr Postoperative

干预措施: Ceftriaxone 2000 mg (Drug)

ceftriaxone 10 grams

Experimental

Multiple doses 2 grams of ceftriaxone every 24 hrs for 5 days

干预措施: Ceftriaxone 2000 mg (Drug)

结局指标

主要结局

assessment of incidence rate of surgical site infection

时间窗: baseline

surgical site infection are further classified as either superficial or deep. Superficial infections involve only the skin and subcutaneous tissue, whereas deep infections involve deep tissue spaces or organs

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

ibram romany labib nashed

resident

Assiut University

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