Clinical trial NCT06763211: Effect of Chlorhexidine Gluconate Hair Bath on the Development of Surgical Site Infection and Time to Discharge
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infection Secondary to Surgical Procedure
Keywords: Cranial surgery
Surgical site infection
Hair bath
chlorhexidine gluconate
Lead sponsor: Akdeniz University Hospital
Sponsor class: OTHER
Collaborators: name: Serpil İNCE
First posted: 2025-01-08
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

H 1_1: Chlorhexidine gluconate hair bath has an effect on the development of surgical site infection in patients planned for cranial surgery.

H0_2: Chlorhexidine gluconate hair bath has no effect on the time to discharge in patients planned for cranial surgery.

H1_2: Chlorhexidine gluconate hair bath has an effect on the duration of discharge in patients planned for cranial surgery.

The research is a randomized controlled, single-blind experimental research design.

The population of the research will consist of patients scheduled for cranial surgery at Akdeniz University Hospital Brain and Nerve Surgery Clinic. The sample of the study will consist of patients who meet the inclusion criteria for cranial surgery planned at Akdeniz University Hospital Brain and Nerve Surgery Clinic. In order to calculate the sample size, the power of the study, type 1 error, and effect size parameters were determined with the guidance of similar study data. The sample size was calculated with the support of a statistical consultant. G\*Power 3.1.9.4 in calculating the sample size. statistical program was used. In this program, a total of 224 individuals were determined, including 75 intervention 1 group, 75 intervention 2 group, and 74 control group, with an effect size of 96%, 80% power and a margin of error of 0.05. Considering the possibility of sample loss in the study with statistical consultancy, 10% more of the calculated sample was included in the randomization process. It was decided to include a total of 252 people in randomization: 84 in the intervention 1 group, 84 in the intervention 2 group, and 84 in the control group.

This study is planned to be conducted with patients admitted to Research Akdeniz University Hospital Brain and Nerve Surgery Clinic for planned cranial surgery. Patients who meet the planned inclusion criteria for cranial surgery will continue to be included in the study until the sample size is reached. The collection of data in the groups and the implementation of nursing interventions will be carried out by the researcher by meeting the patients face to face. After patients scheduled for cranial surgery are admitted to the clinic, information about the research will be given in the patient room, informed consent will be obtained and an implementation plan will be made. For patients scheduled for cranial surgery who agree to participate in the study and meet the inclusion criteria, the Patient Descriptive Characteristics and Preoperative Period Information Form will be filled out by the researcher together with the patient. The Surgical Site Infection Follow-up Form will be filled out daily by the investigator while observing the cranial surgical area. Laboratory Findings Form, Vital Signs Form and Culture Follow-up Form will be written by the researcher by following the nurse observation forms and the computer system where the patient data are recorded. It is planned to give brochures regarding the care of the surgical field to patients and their relatives before discharge. Patients included in the research will be assigned to groups by a simple randomization method by a statistician outside the thesis.

1. Research Application Steps for Patients in Intervention 1 Group: 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.
2. Research Application Steps for Patients in Intervention 2 Group: 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.
3. Research Application Steps for Patients in the Control Group: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Culture Tracking Form
timeFrame: 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
measure: Surgical Site Infection Follow-up Form
timeFrame: It will be applied every day (once a day), starting from the 2nd postoperative day to 7th postoperative day.
measure: Length of hospital stay
timeFrame: Until Primary Completion is completed. up to 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
References: