Effect of Chlorhexidine Gluconate Hair Bath on the Development of Surgical Site Infection and Time to Discharge in Patients Scheduled for Cranial Surgery: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Culture Tracking Form
研究概览
简要总结
One of the most important preventable complications occurring in the postoperative period is surgical site infections. Surgical site infections (SSI) are infections that occur in incisions, organs or organ spaces that occur after surgery. The mortality rate of patients who develop SSI is twice as high as that of patients who do not develop infection, the duration of intensive care stay increases by 60%, and the rate of hospital admission after discharge is five times higher. As the number of surgical procedures and procedures continues to increase, preventing surgical site infections becomes increasingly important. One of the reasons for infection after cranial surgery is the patient's scalp flora. The skin and scalp have the potential to cause many bacterial and harmful fungal infections. The Center for Disease Control and Prevention (CDC) recommends that patients take a shower/bath with soap or an antiseptic solution at least one night before the day of surgery. Although there is no definitive evidence that this practice reduces surgical site infections, the fact that most surgical site infections are caused by microorganisms on the skin supports the recommendation.
The research was planned as a randomized controlled, single-blind experimental study. The sample will be divided into three groups in total, two intervention groups and one control group, by randomization method. The intervention 1 group will have a hair bath with chlorhexidine the evening before the operation, the intervention 2 group will first have a hair bath with the product used by the patient and then with chlorhexidine, and the control group will have a hair bath with the soap/shampoo the patient uses himself. The product available on the market will be used. The hair of patients in intervention groups 1 and 2 will be washed twice, using 5 ml of chlorhexidine each time. After applying the solution, it will be left for 1 minute and then rinsed. After rinsing, the hair will be dried with a disposable towel.
The purpose of this study; The aim of this study is to evaluate the effect of hair bath with chlorhexidine solution on the occurrence of SSI and discharge time in patients scheduled for cranial surgery in the brain and neurosurgery clinic.
详细描述
This study; It is thought that it will increase the awareness of nurses about preoperative shower/bath and hair bath in brain and neurosurgery clinics, help the implementation of shower/bath and hair bath protocols in clinics, and be effective in preventing surgical site infections.
The research was planned to determine the effect of hair bath using soap/shampoo, chlorhexidine gluconate solution and both in the evening before surgery on surgical site infection and discharge time in preventing surgical site infection on the scalp in patients scheduled for cranial surgery.
UNIQUE VALUE:
This research will be conducted based on the following hypotheses:
H0_1: Chlorhexidine gluconate hair bath has no effect on the development of surgical site infection in patients planned for cranial surgery.
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
- Single (Participant)
盲法说明
Statistics Expert
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18 years or older
- •Having elective surgery
- •The patient agrees to participate in the study
- •Having cranial surgery for the first time
- •No irritated open wound on the scalp
- •No systemic infection such as sepsis, pneumonia, blood infections or intracranial infection such as meningitis or abscess
- •Not having a mental illness that would prevent communication
排除标准
- •Be under 18 years of age
- •There is deterioration in the integrity of the cranium and emergency cranial surgery is planned
- •Not volunteering to participate in the research
- •Having received oncological treatment
- •Having a systemic or intracranial infection
- •Transsphenoidal surgical intervention is planned
- •Having a mental illness that prevents communication
- •Being allergic to chlorhexidine
研究组 & 干预措施
Intervention 1
Hair bath will be applied to the patient by the researcher. Before the hair bath, the patient's eyes will be covered with gauze and cotton tampons will be used for the ears. Hair bath will be done with 5 ml chlorhexidine gluconate solution at the patient's bed. After the hair is wetted, chlorhexidine gluconate will be applied to the entire scalp and hair, the scalp and hair will be rubbed with gentle movements for 5 minutes and left for 1 minute before rinsing. Application of the solution will be repeated twice. It will be rinsed after waiting for a minute. It will be dried with disposable towels. A swab of 2 cm2 will be taken from the scalp with a culture stick by rolling it back and forth for 15 seconds. An area of 2 cm2 will be taken from the area where the patient will be surgically cut.
干预措施: Chlorhexidine Hair Bath (Procedure)
Intervention 2
Hair bath will be applied to the patient by the researcher. Before the hair bath, the patient's eyes will be covered with gauze and cotton tampons will be used for the ears. First, the researcher will give a hair bath using the patient's soap or shampoo. In the same way, it will be rubbed for 5 minutes and left for 1 minute before rinsing. Secondly, the patient will be given a hair bath with 5 ml of chlorhexidine gluconate solution. It will be rubbed with chlorhexidine gluconate for 5 minutes and left for 1 minute before rinsing. Application of the solution will be repeated twice. The patient's hair will be dried with a disposable towel. A swab of 2 cm2 will be taken from the scalp with a culture stick by rolling it back and forth for 15 seconds. An area of 2 cm2 will be taken from the area where the patient will be surgically cut.
干预措施: Chlorhexidine Hair Bath (Procedure)
Control
Hair bath will be applied to the patient by the researcher. Hair bath will be given using the patient's own soap or shampoo. Before the hair bath, the patient's eyes will be covered with gauze and cotton tampons will be used for the ears. The soap or shampoo will be applied to the scalp and hair by rubbing with gentle movements for 5 minutes and then left for one minute. After the hair and scalp are rinsed, they will be dried with disposable towels. A swab of 2 cm2 will be taken from the scalp with a culture stick by rolling it back and forth for 15 seconds. An area of 2 cm2 will be taken from the area where the patient will be surgically cut.
结局指标
主要结局
Culture Tracking Form
时间窗: First culture taken at preop morning after hair bath, second culture taken on 2nd postop day, and 3rd culture taken just before surgical site stitches removed 12th day
Within the scope of the research, the date of culture taken from the surgical area will be recorded and will be used to follow up the results. The culture collection times were after washing, on the 2nd post-operative day, and on the 12th day after the stitches were removed. or 15th day\]. The last culture sample will be taken on the day the stitches are removed.
Surgical Site Infection Follow-up Form
时间窗: It will be applied every day (once a day), starting from the 2nd postoperative day to 7th postoperative day.
This form, created by the researcher using the relevant literature, consists of two parts. In the first section, there are 17 questions that include patients' data regarding the operation and surgical field. Surgery performed, date, time, duration, duration of stay in intensive care, duration of hospital stay after surgery, date of discharge, duration of antibiotic use, steroids, immunosuppressive and antidiabetic drugs used, postoperative blood transfusion, number and type of drains, withdrawal time, culture from the wound site. It includes questions about the date of collection, how the patient was treated for discharge in the surgical area, whether there is infection in the surgical area, culture results, and the presence of repeated hospitalization
Length of hospital stay
时间窗: Until Primary Completion is completed. up to 15 days
The patient's hospital stay will be evaluated with data from patient records, covering the period from the first day of hospitalization to when the patient leaves the clinic.
次要结局
未报告次要终点
研究者
HAVVA ÇOŞKUN
Akdeniz University
Akdeniz University Hospital