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

NCT06801275 | Active Not Recruiting DMC

• 2 other identifiers: 202407035912024-116
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

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.

Conditions

Surgical Site Infections; Lumbar Disc Herniation

Keywords

surgical site infections; 4% Chlorhexidine Gluconate

Outcome Measures

Primary Outcomes (1)

• surgical site infection

  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

Study Arms (2)

The effect of 1 shower with 4% chlorhexidine gluconate on surgical site infections

EXPERIMENTAL

Patients will be showered with 4% chlorhexidine gluconate 1 time on the night before surgery.

Other: 1 shower with 4% chlorhexidine gluconate

The effect of 2 shower with 4% chlorhexidine gluconate on surgical site infections

OTHER

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

Interventions

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

Also known as: They will be provided to shower with 4% chlorhexidine gluconate once on the night before surgery.

The effect of 1 shower with 4% chlorhexidine gluconate on surgical site infections

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

Also known as: showering with 4% chlorhexidine gluconate twice, the night before and the morning of surgery

The effect of 2 shower with 4% chlorhexidine gluconate on surgical site infections

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to communicate verbally

You may not qualify if:

• 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.

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead

Study Sites (2)

Çanakkale on Sekiz Mart University

Çanakkale, Merkez, 17100, Turkey (Türkiye)

Location

Çanakkale on Sekiz Mart Üniversity

Çanakkale, Merkez, 17100, Turkey (Türkiye)

Location

Related Publications (10)

• Sway A, Solomkin JS, Pittet D, Kilpatrick C. Methodology and Background for the World Health Organization Global Guidelines on the Prevention of Surgical Site Infection. Surg Infect (Larchmt). 2018 Jan;19(1):33-39. doi: 10.1089/sur.2017.076. Epub 2017 May 4.

  PMID: 28472604 BACKGROUND

• Young H, Bliss R, Carey JC, Price CS. Beyond core measures: identifying modifiable risk factors for prevention of surgical site infection after elective total abdominal hysterectomy. Surg Infect (Larchmt). 2011 Dec;12(6):491-6. doi: 10.1089/sur.2010.103. Epub 2011 Dec 5.

  PMID: 22142313 BACKGROUND

• McClelland S 3rd, Hall WA. Postoperative central nervous system infection: incidence and associated factors in 2111 neurosurgical procedures. Clin Infect Dis. 2007 Jul 1;45(1):55-9. doi: 10.1086/518580. Epub 2007 May 21.

  PMID: 17554701 BACKGROUND

• Abode-Iyamah KO, Chiang HY, Winslow N, Park B, Zanaty M, Dlouhy BJ, Flouty OE, Rasmussen ZD, Herwaldt LA, Greenlee JD. Risk factors for surgical site infections and assessment of vancomycin powder as a preventive measure in patients undergoing first-time cranioplasty. J Neurosurg. 2018 Apr;128(4):1241-1249. doi: 10.3171/2016.12.JNS161967. Epub 2017 May 12.

  PMID: 28498056 BACKGROUND

• Aldrich A, Kuss MA, Duan B, Kielian T. 3D Bioprinted Scaffolds Containing Viable Macrophages and Antibiotics Promote Clearance of Staphylococcus aureus Craniotomy-Associated Biofilm Infection. ACS Appl Mater Interfaces. 2019 Apr 3;11(13):12298-12307. doi: 10.1021/acsami.9b00264. Epub 2019 Mar 21.

  PMID: 30855125 BACKGROUND

• AORN. (2014). Preoperative Standards and Recommended Practices. Denver, CO: AORN, pp. 445-463.

  BACKGROUND

• Berrios-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 Aug 1;152(8):784-791. doi: 10.1001/jamasurg.2017.0904.

  PMID: 28467526 BACKGROUND

• Damkliang J, Considine J, Kent B, Street M. Nurses' perceptions of using an evidence-based care bundle for initial emergency nursing management of patients with severe traumatic brain injury: A qualitative study. Int Emerg Nurs. 2015 Oct;23(4):299-305. doi: 10.1016/j.ienj.2015.04.004. Epub 2015 Jun 3.

  PMID: 26049810 BACKGROUND

• Edmiston CE Jr, Leaper D. Should preoperative showering or cleansing with chlorhexidine gluconate (CHG) be part of the surgical care bundle to prevent surgical site infection? J Infect Prev. 2017 Nov;18(6):311-314. doi: 10.1177/1757177417714873. Epub 2017 Jul 26.

  PMID: 29344102 BACKGROUND

• Liu H, Dong X, Yin Y, Chen Z, Zhang J. Reduction of Surgical Site Infections After Cranioplasty With Perioperative Bundle. J Craniofac Surg. 2017 Sep;28(6):1408-1412. doi: 10.1097/SCS.0000000000003650.

  PMID: 28692506 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection; Intervertebral Disc Displacement

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Study Officials

• araz askeroğlu

  çanakkale on sekiz mart university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants will not know which experimental group they are in
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. D.

Model Details: 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.

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 30, 2025
• Study Start: July 1, 2024
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)