The Effect of Number of Showers With 4% Chlorhexidine Gluconate on Prevention of Surgical Site Infections (SSI)

September 16, 2025 updated by: Araz ASKEROĞLU, Çanakkale Onsekiz Mart University

The Effect of Number of Showers With 4% Chlorhexidine Gluconate Before Lumbar Disc Herniation Surgery on Prevention of Postoperative Surgical Site Infections: A Single-Blind Randomized Controlled Trial

Surgical site infections (SSIs) are the most common type of nosocomial infection in surgical departments.

Although lumbar disc herniation (LDH), which is one of the common cases in neurosurgery, is a serious problem affecting postoperative SSI, morbidity and mortality, there are not enough studies on its prevention in the literature.

In the literature, there are studies on showering with chlorhexidine or other antiseptic solutions in the preoperative period to prevent SSI, but there is no study on whether the number of showers performed in the preoperative period is effective on SSI.

In this study, the effect of showering with 4% chlorhexidine gluconate before lumbar disc herniation surgery on postoperative surgical site infections will be examined. It is aimed to compare the effect of douching with 4% Chlorhexidine Gluconate before lumbar disc hernia surgery on surgical site infections. Since there are not enough studies in the literature, this study is an innovative study. In this study, it is thought that washing the surgical site with antiseptic soap containing 4% Chlorhexidine Gluconate before LDH surgery will have an effect on surgical site infections.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Lumbar disc herniation surgery is performed in two ways: open discectomy and microdiscectomy. In open discectomy, the skin incision is made large enough to expose the lamina and to create an area where the retractor can work with the naked eye. After the lamina is exposed, the correct distance is determined by feeling the sacrum with the fingers. Scopy assistance may be required in suspicious cases. Bone tissue is removed from the lamina to the beginning of the ligamentum flavum without damaging the facet joints. Then the ligament is removed and discectomy is performed by pushing the dura and nerve root inwards. In microdiscectomy, a smaller incision (1.5-2 cm) is made. Special retractors or tubes are inserted. Partial hemilaminotomy and discectomy are performed using microscope and microsurgical instruments.

Although the incidence of SSI after LDH surgery is not known with certainty, patients usually have various potential risk factors for CAI such as advanced age, malnutrition due to loss of appetite, and steroid use. All surgical patients are at risk for developing SSI. For patients, SSI can cause pain and discomfort, financial losses, and impaired quality of life. These infections can lead from a simple incision site abscess with purulent discharge to a complex infection that can contribute to a life-threatening condition and possible morbidity. Therefore, accurate monitoring of SSI and confirmation of the diagnosis of SSI are very important and vital for patients.

The main causative microorganisms of SSI in the preoperative period are gram-positive cocci, which are common bacterial colonies of the skin. Therefore, although WHO recommends showering with normal or antiseptic soap before surgical intervention, it is thought that the use of antiseptic soap will be more effective to destroy a larger number of skin pathogens both before and during surgical intervention.. For this reason, it was deemed appropriate to wash the surgical areas of the patients with antiseptic soap containing 4% chlorhexidine gluconate before surgery.

In the literature, there are studies showing that many factors related to the perioperative process and surgical procedure increase the risk of developing SSI. Among these, there are studies showing that bathing with an antimicrobial agent before surgical intervention reduces the overall bacterial load in the skin's own flora, thus reducing the risk of SSI.

Although there are evidence-based recommendations and some improved care practices to prevent SSI in the literatüre, there is no standardised practice with proven efficacy today. This study is a randomised controlled experimental design and requires a team approach consisting of physicians and nurses in line with the existing evidence recommendations. Therefore, it is thought that showering the operation area with antiseptic soap containing 4% Chlorhexidine Gluconate before lumbar disc herniation surgery will be effective in reducing SSI.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Merkez
      • Çanakkale, Merkez, Turkey (Türkiye), 17100
        • Çanakkale on Sekiz Mart Üniversity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • to communicate verbally

Exclusion Criteria:

  • Patients with diabetes mellitus side disease, pylolidal cyst surgery, any surgical history from the lumbar region and patients who will undergo lumbar disc hernia stabilisation surgery will not be included.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The effect of 1 shower with 4% chlorhexidine gluconate on surgical site infections
Patients will be showered with 4% chlorhexidine gluconate 1 time on the night before surgery.
Other: 1 shower with 4% chlorhexidine gluconate
Comparison of the effect of showering once with 4% Chlorhexidine Gluconate before lumbar disc herniation surgery on surgical site infections
Other Names:
  • They will be provided to shower with 4% chlorhexidine gluconate once on the night before surgery.
Other: The effect of 2 shower with 4% chlorhexidine gluconate on surgical site infections
patients will be provided to shower with 4% chlorhexidine gluconate twice, the night before and the morning of the operation.
Other: 2 shower with 4% chlorhexidine gluconate
Comparison of the effect of showering twice with 4% Chlorhexidine Gluconate before lumbar disc herniation surgery on surgical site infections
Other Names:
  • showering with 4% chlorhexidine gluconate twice, the night before and the morning of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgical site infection
Time Frame: 30 days following surgical intervention
Following the surgical intervention, the surgical site will be monitored for purulent discharge, abscess or cellulitis for 30 days. The patients will be followed up by the investigator and the specialist physician in the clinic until discharge and by the investigator after discharge. In the postoperative period, purulent discharge, abscess or cellulitis that develops in the surgical site within 30 days following the surgical intervention will be defined as SSI with the approval of the specialist physician.
30 days following surgical intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Çanakkale Onsekiz Mart University

Investigators

  • Study Director: araz askeroğlu, Çanakkale on Sekiz Mart Üniversity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

December 15, 2025

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

January 30, 2025

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20240703591
  • 2024-116 (Other Grant/Funding Number: Fredrik och Ingrid Thurings stiftelse)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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