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NCT Number: NCT06801275

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Çanakkale on Sekiz Mart University, Çanakkale, Merkez, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1 shower with 4% chlorhexidine gluconate

Other

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.

2 shower with 4% chlorhexidine gluconate

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Çanakkale Onsekiz Mart University

Other

Registry information

Official study title

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

Acronym: SSI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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