Clinical trial NCT06801275: The Effect of Number of Showers With 4% Chlorhexidine Gluconate on Prevention of Surgical Site Infections
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Surgical Site Infections
Lumbar Disc Herniation
Keywords: surgical site infections
4% Chlorhexidine Gluconate
Lead sponsor: Çanakkale Onsekiz Mart University
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients to be included in the study will be assigned to experiment-1 or experiment-2 groups by simple randomisation. Routine treatment and care processes in the clinic will be continued for both groups of patients. Experiment 1 group patients will be showered with 4% chlorhexidine gluconate once on the preoperative night. In the experimental group 2 patients, they will be provided to take a shower with 4% chlorhexidine gluconate twice, once on the preoperative night and once on the morning of the operation, by rubbing the waist area for 10 minutes. the effect of the intervention will be evaluated in the postoperative period.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: surgical site infection
timeFrame: 30 days following surgical intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Çanakkale
country: Turkey
facility: Çanakkale on Sekiz Mart University
state: Merkez
city: Çanakkale
country: Turkey
facility: Çanakkale on Sekiz Mart Üniversity
state: Merkez
Study officials:
affiliation: çanakkale on sekiz mart university
name: araz askeroğlu
role: STUDY_DIRECTOR
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