Preoperative Bath in Patients Submitted to Hip Arthroplasty: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Infection of Surgical Site (SSI)
研究概览
简要总结
Clinical trial for prevention, randomized, controlled, blinded, parallel, with three arms which purpose is verify the effects of nursing intervention preoperative bathing with 4% chlorhexidine gluconate, 10% Povidone iodine (PVPI) and soap without antiseptic, for the prevention of surgical site infection (SSI) in patients undergoing hip arthroplasty.
详细描述
Despite the recommendation in several guidelines of preoperative bathing with 4% chlorhexidine gluconate as a measure for the prevention of SSI, there is no evidence in the literature that support this practice. The objective of this study is to evaluate the effect of nursing intervention: preoperative bath using 4% chlorhexidine gluconate solutions, 10% povidone iodine degermante or soap without antiseptic for the prevention of SSI in patients undergoing elective hip arthroplasty surgery. The specific objectives are to compare the incidence of SSI in the three interventions, to assess the most effective intervention for the prevention of surgical infection and to estimate the frequency of allergic reactions caused by the use of the solutions. Two intervention groups (4% Chlorhexidine gluconate and PVPI10%) and a control group (without antiseptic soap) composed of 52 patients undergoing hip arthroplasty in each group will be randomized to perform the baths in the period from may 2015 to june 2017. Before the intervention, nasal swabs will be collected of patients to investigate colonization by Staphylococcus aureus.
The expected result is lower ISC rate with the proposed measures.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be 18 or older;
- •Elective procedure of total hip arthroplasty
- •No report of infectious focus at the surgical site
- •Know to respond to the clinical signs of a surgical infection or having a person responsible with this ability
- •Do not be a nasal carrier of Staphylococcus aureus before surgery
- •Have access to fixed or mobile phone
排除标准
- •Patient treating surgical site infection
- •Emergency hip prosthesis surgery or orthopedic trauma
- •Nasal carriers of Staphylococcus aureus before surgery
- •Previous history of allergic reactions to the products used in the bat
研究组 & 干预措施
Bathing with10% PVPI degermante
Two baths with PVPI using precise methods, including to scrubb the whole body with 50mL of undiluted solution for each bath, at night before surgery and the morning of surgery.
干预措施: 10% PVPI degermante (Device)
Bathing with soap without antiseptic.
Two baths with soap using precise methods, including to scrubb the whole body with 50mL of undiluted solution for each bath, at night before surgery and the morning of surgery.
干预措施: Soap without antiseptic (Device)
Bathing with 4% Chlorhexidine gluconate
Two baths with chlorhexidine using precise methods, including to scrubb the whole body with 50mL of undiluted solution, at night before surgery and the morning of surgery.
干预措施: 4% Chlorhexidine gluconate (Device)
结局指标
主要结局
Infection of Surgical Site (SSI)
时间窗: During the first 90 days after surgery
The infections that develop after the surgical procedure
次要结局
- Allergic reactions(In the first hours after procedure)
研究者
Lucia Maciel de Castro Franco
PhD
Federal University of Minas Gerais