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临床试验/NCT03595852
NCT03595852已完成不适用

Preoperative Antibiotic Prophylaxis Versus Placebo in Clean, Non-prosthetic Surgery at CHUK. Impact on Surgical Site Infections and Patient Cost.

University of Rwanda1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2018年3月1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
已完成
入组人数
138
试验地点
1
主要终点
Surgical site infection

研究概览

简要总结

This is a randomized control study of antibiotic uses in clean non prosthetic surgeries. One group will be given antibiotic prophylaxis, other will receive a placebo. The primary outcome will be the rate of surgical site infection in 2 groups.

详细描述

I will conduct a randomized controlled trial (RCT) of antibiotic prophylaxis versus placebo in clean, non-prosthetic, elective procedures. The intervention will be a single dose of prophylactic antibiotic (cefazolin): 2 gr in adults or 3 gr for patients weighing >120Kg and 30mg/kg in children) within 30-60 minutes prior to skin incision. The control group will receive a similarly prepared placebo injection (water for injection) 30-60 minutes prior to incision.

I will randomize patients in a 1:1 allocation ratio using a simple randomization. Patients will randomly pick an envelope with a number allocating to antibiotic prophylaxis or placebo. Patients and caretakers will be blinded to the intervention. The surgeon will also be blinded to the intervention. The antibiotic (or placebo) will be pre-mixed by the study investigator and administered by the anesthetist.

Other preventive measures for surgical site infection (SSIs) such as effective surgical hand scrub, proper skin preparation with povidone and sterility of materials and instrument will be applied systematically in all groups. Dressing of the wound will be removed 48 hours after operation and no further dressing will be required. Patients will be followed for development of SSI documented by surgeon at discharge and will be called after 30 days of surgery to address any sign of SSI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

盲法说明

patients and investigator will be blinded for intervention

入排标准

性别
All
接受健康志愿者

入选标准

  • - All elective non-prosthetic surgical procedures such as hernia, thyroid, hydrocele, undescended testes surgery, removal of orthopedic implants, low risk breast surgical procedures and other all procedures deemed to be clean.

排除标准

  • - Emergency cases
  • Any patient with American Society of Anesthesiologists Score (ASA)>2
  • Procedures lasting more than 2 hours
  • Patients who were taking antibiotics 2 days prior to operation

研究组 & 干预措施

Prophylaxis

Experimental

The intervention will be a single dose of prophylactic antibiotic (cefazolin): 2 gr in adults or 3 gr for patients weighing >120Kg or 30mg/kg in children given within 30-60 minutes prior to skin incision.

干预措施: Cefazolin (Drug)

No prophylaxis

Placebo Comparator

The control group will receive a similarly looking prepared placebo injection (normal saline placebos for injection) 30-60 minutes prior to incision.

干预措施: Placebos (Drug)

结局指标

主要结局

Surgical site infection

时间窗: 30 days post operative

surgical wounds will be accessed for signs of surgical site infection at discharge by a treating surgeon and patients will be called 30 days after operation for signs of surgical site infection

次要结局

  • mortality(48 hours post operation)
  • morbidity(48 hours post operation)

研究者

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

Isaie Sibomana

Resident in surgery

University of Rwanda

研究点 (1)

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