Effect of Chlorhexidine Gluconate Hair Bath on the Development of Surgical Site Infection and Time to Discharge

NCT06763211 | Active Not Recruiting DMC

• 1 other identifier: AkdenizNeurology
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection Secondary to Surgical Procedure

Keywords

Cranial surgery; Surgical site infection; Hair bath; chlorhexidine gluconate

Outcome Measures

Primary Outcomes (3)

• Culture Tracking Form

  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.

  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

• Surgical Site Infection Follow-up Form

  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

  It will be applied every day (once a day), starting from the 2nd postoperative day to 7th postoperative day.

• Length of hospital stay

  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.

  Until Primary Completion is completed. up to 15 days

Study Arms (3)

Intervention 1

EXPERIMENTAL

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.

Procedure: Chlorhexidine Hair Bath

Intervention 2

EXPERIMENTAL

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.

Procedure: Chlorhexidine Hair Bath

Control

NO INTERVENTION

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.

Interventions

Chlorhexidine Hair Bath PROCEDURE

Intervention group 1 will have a hair bath with 5 ml of chlorhexidine gluconate solution 2 times consecutively. Intervention group 2 will first be given a hair bath using the patient's soap or shampoo. Afterwards, the hair will be bathed 2 times consecutively with 5 ml chlorhexidine gluconate solution. Hair bath will be given to the control group using the patient's own soap or shampoo. Surgical site infection follow-up form, laboratory findings form, vital signs form, culture follow-up form will be filled out before and after banyadon. Additionally, cultures will be taken from the surgical area with hair immediately after bathing, on the 2nd post-operative day, and on the day the stitches are removed.

Intervention 1; Intervention 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HAVVA ÇOŞKUN: lead
• Serpil İNCE: collaborator

Study Sites (1)

Akdeniz University

Antalya, 07070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Statistics Expert
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Akdeniz University

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: January 8, 2025
• Study Start: July 24, 2023
• Primary Completion: June 25, 2025
• Study Completion: September 1, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)