Education Video for Reducing Infections

No longer recruiting at 3 trial locations

Overseen By Angelo Volandes, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Chlorhexidine allergy, Comfort care

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a short video can help hospital patients properly use a special cleaning cloth called chlorhexidine gluconate (CHG) to reduce the risk of serious blood infections. The study compares patients who receive the usual written and spoken instructions with those who also watch an educational video about CHG bathing. The goal is to determine if the video improves patients' understanding and adherence to the cleaning routine. Patients who require CHG skin treatment and are not allergic to it may be suitable for this trial. As an unphased trial, this study offers patients the opportunity to contribute to innovative educational methods that could enhance hospital care practices.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this educational video is safe for patient use?

Research has shown that using chlorhexidine gluconate (CHG) for bathing effectively lowers the risk of infections in hospitals. Studies have found that daily CHG baths help stop the spread of germs, reducing infection rates. CHG is commonly used and generally safe, with few serious side effects. Most people can use it without issues, though some might experience mild skin irritation.

This trial tests an educational video designed to teach proper CHG use. The video is safe because it is educational, not a treatment. Its goal is to improve understanding and adherence to CHG bathing instructions, which has proven to be a safe and effective way to reduce infections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it leverages technology to enhance patient education and potentially reduce infections. Unlike traditional educational documents, this trial introduces the use of a CHG (chlorhexidine gluconate) bathing video, accessible through QR codes or unit iPads, making it more engaging and easier for patients to understand and follow. By offering a visual and interactive method of learning, it aims to improve patient compliance and outcomes. This approach could lead to more effective patient education and ultimately better infection prevention, making it a promising innovation in the healthcare field.

What evidence suggests that this video is effective for reducing infections?

Research has shown that using chlorhexidine gluconate (CHG) for bathing can greatly reduce infection rates in hospitals. Studies have found that CHG baths can decrease central line-associated bloodstream infections (CLABSI) from 5.31 to 0.69 infections per 1,000 central line days. This germ-killing wash also lowers harmful bacteria on the skin, reducing the risk of infection for several hours. Daily CHG baths make it less likely for patients to catch hard-to-treat germs. In this trial, participants in the intervention group will have access to a CHG bathing video to enhance understanding and compliance. Although the use of educational videos specifically for CHG bathing has not been studied, videos have proven effective in helping patients understand other healthcare topics. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for hospitalized patients who need CHG skin treatment to prevent bloodstream infections. It's not for those with a history of CHG allergy or patients receiving end-of-life comfort care.

Inclusion Criteria

I need a CHG skin treatment in the hospital.

Exclusion Criteria

I am receiving care focused on my comfort.

History of CHG allergy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Patients in the intervention group are provided access to a CHG bathing video through QR codes and unit iPads, followed by a voluntary questionnaire.

4 weeks

Inpatient stay

Control

Patients in the control group receive usual care with the current educational document available for CHG bathing.

4 weeks

Inpatient stay

Follow-up

Participants are monitored for compliance with CHG bathing and infection rates.

Up to 12 months

What Are the Treatments Tested in This Trial?

Interventions

• CHG Skin Treatment Video

Trial Overview The study tests the effectiveness of an educational video on how and why to perform CHG bathing, which helps reduce infection risks in hospitalized patients with central lines.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Intervention Group: In addition to the current educational document available for CHG bathing, patients in the intervention group would be provided access to a CHG bathing video through multiple avenues (QR codes placed in the room/unit, video provided on unit iPads). Nurses will be instructed to provide QR codes to patients to scan and watch the video. Patients can scan the QR code using their own smart device or through unit-based iPads. After viewing the video, there is another QR code to scan that goes to a short patient survey.

Group II: Control Group Active Control 1 Intervention

Control Group: Patients in the control group would have access to the current education available (patient education document) - usual care

CHG Skin Treatment Video is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Chlorhexidine Gluconate for:

• Skin disinfection before surgery
• Wound cleaning
• Preventing dental plaque
• Treating yeast infections of the mouth
• Keeping urinary catheters from blocking

Approved in European Union as Chlorhexidine Gluconate for:

• Skin disinfection before surgery
• Wound cleaning
• Preventing dental plaque
• Treating yeast infections of the mouth
• Keeping urinary catheters from blocking

Approved in Canada as Chlorhexidine Gluconate for:

• Skin disinfection before surgery
• Wound cleaning
• Preventing dental plaque
• Treating yeast infections of the mouth
• Keeping urinary catheters from blocking

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Advanced Care Planning Decisions

Collaborator

Trials

1

Recruited

1,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Indiana University Health

Collaborator

Trials

35

Recruited

18,500+

Published Research Related to This Trial

Hypochlorous acid (HA) 0.01% demonstrated immediate bactericidal effects against various skin microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA) and Candida albicans, making it a highly effective antiseptic.

In comparison to other antiseptics like isopropyl alcohol (IPA), chlorhexidine gluconate (CHG), and povidone iodine (PI), HA showed equal or superior efficacy, suggesting it could be a valuable alternative for skin disinfection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

0.01% Hypochlorous Acid as an Alternative Skin Antiseptic: An In Vitro Comparison. Anagnostopoulos, AG., Rong, A., Miller, D., et al.[2019]

Topical application of chlorhexidine gluconate (CHG) using washcloths significantly reduces the risk of central-line-associated bloodstream infections (CLABSI) and surgical site infections (SSI), with incidence rate ratios of 0.43 and 0.29 respectively, based on a systematic review of 20 studies.

CHG washcloths also lower colonization rates of vancomycin-resistant enterococci (VRE) and meticillin-resistant Staphylococcus aureus (MRSA), but there was no significant reduction in infection rates for these bacteria, indicating that while CHG is effective in reducing colonization, it may not directly prevent infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of non-rinse skin cleansing with chlorhexidine gluconate on prevention of healthcare-associated infections and colonization with multi-resistant organisms: a systematic review. Karki, S., Cheng, AC.[2022]

The study found that both 1% chlorhexidine-gluconate/61% ethanol (CHG/Ethanol) emollient and 7.5% povidone-iodine (PVI) scrub had similar antimicrobial effects, with no significant difference in the number of microorganisms present immediately after surgical scrubs and after operations.

However, CHG/Ethanol emollient was associated with better skin condition and higher satisfaction among users compared to PVI, suggesting it may be a preferable option for surgical scrubs in terms of user comfort and skin health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of a waterless, scrubless chlorhexidine gluconate/ethanol surgical scrub and povidone-iodine for antimicrobial efficacy]. Choi, JS.[2019]

Chlorhexidine gluconate (CHG) and mupirocin were estimated to decolonize approximately 15% of patients with MRSA per application, indicating their effectiveness in reducing MRSA colonization in an ICU setting.

The study suggests that there is potential for improving MRSA decolonization strategies, as delays in administration of these agents still resulted in significant reductions in MRSA transmission, highlighting their robustness despite concerns over patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimated Methicillin-Resistant Staphylococcus aureus Decolonization in Intensive Care Units Associated With Single-Application Chlorhexidine Gluconate or Mupirocin. Lofgren, ET., Mietchen, M., Dicks, KV., et al.[2021]

Chlorhexidine Gluconate (CHG) and its derivatives can cause severe eye and ear damage, even with minimal exposure during surgical preparations, leading to serious conditions like corneal injury and potential blindness.

In contrast, 10% Povidone-Iodine (PI) solutions show minimal toxicity to the eyes and ears while providing similar effectiveness in preventing surgical site infections, making them a safer alternative for preoperative skin preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Perspective on ocular toxicity of presurgical skin preparations utilizing Chlorhexidine Gluconate/Hibiclens/Chloraprep. Epstein, NE.[2022]

The review analyzed six randomized controlled trials to compare the antimicrobial efficacy and safety of various antiseptics for preoperative skin preparation, including combinations of chlorhexidine gluconate and isopropyl alcohol, and other antiseptics like povidone-iodine.

Results indicated that 2% chlorhexidine gluconate combined with 70% isopropyl alcohol (ChloraPrep) showed superior immediate and persistent antimicrobial efficacy compared to other antiseptics, suggesting it may be the best option for preventing nosocomial infections during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analyses comparing the antimicrobial activity and safety of current antiseptic agents: a review. Hibbard, JS.[2019]

In a study involving 63 participants, using 2% chlorhexidine gluconate (CHG)-impregnated cloths resulted in significantly higher residual CHG concentrations and lower bacterial densities on the skin compared to 4% CHG liquid cleansing methods.

The 2% CHG cloth method showed residual concentrations of 2500 µg/mL immediately after cleansing and 1250 µg/mL after 6 hours, indicating its potential effectiveness in reducing infection risk in ICU patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential Effects of Chlorhexidine Skin Cleansing Methods on Residual Chlorhexidine Skin Concentrations and Bacterial Recovery. Rhee, Y., Palmer, LJ., Okamoto, K., et al.[2021]

Daily bathing with chlorhexidine gluconate (CHG) significantly reduces the number of cultivable cutaneous bacteria and their diversity, indicating its effectiveness as an antiseptic in clinical settings.

The study suggests that higher exposure to CHG correlates with lower minimum inhibitory concentrations and increased antimicrobial susceptibility in coagulase-negative staphylococci, highlighting the need for larger studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of daily chlorhexidine bathing on cutaneous bacterial isolates: a pilot study. Soma, VL., Qin, X., Zhou, C., et al.[2021]

The new chlorhexidine gluconate (CHG) skin prep with a film-forming copolymer demonstrated a 99.999% reduction in microbial activity, maintaining its effectiveness even in the presence of serum, which simulates organic matter like blood.

Importantly, the study found no emergence of resistance to CHG or cross-resistance to antibiotics in the tested strains, indicating that this formulation is both safe and effective for surgical skin antisepsis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of activity and potential for development of antimicrobial resistance to a new tinted 2% chlorhexidine gluconate/70% isopropyl alcohol film-forming sterile preoperative skin preparation. Dormstetter, K., Olson, LKM., Bennaars-Eiden, A., et al.[2020]

Chlorhexidine gluconate (CHG) is a common antiseptic recommended for skin cleansing before central venous catheter insertion, but its safety in children under 2 months is not well established.

Despite limited safety data, CHG is frequently used in Neonatal Intensive Care Units, highlighting a need for further research on its effects in preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of chlorhexidine gluconate used for skin antisepsis in the preterm infant. Chapman, AK., Aucott, SW., Milstone, AM.[2013]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19712033/

Effectiveness of routine patient cleansing with ... Results: Bathing with CHG was associated with a statistically significant decrease in the rate of CVC-associated BSI (from 5.31 to 0.69 cases per 1,000 CVC-days ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8074470/

a stepped wedge cluster randomized trial - PMC Infection prevention champion nurses who worked on the units completed process audits through observation of nursing staff providing CHG baths.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0196655316002005

Effect of chlorhexidine bathing in preventing infections and ... For inguinal skin, there was a 2.5-log reduction in VRE concentrations in the chlorhexidine bathing group that persisted for at least 6-8 hours.

4. link.springer.com link.springer.com/article/10.1007/s11908-025-00865-z

Myths Glorify What Reality Neglects: Efficacy and Safety of ... This review critically examines the efficacy and safety of chlorhexidine gluconate (CHG), the gold-standard antiseptic for infection prevention.

5. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/chg-bathing-to-prevent-healthcareassociated-infections

CHG Bathing to Prevent Healthcare Associated Infections Daily CHG bathing generally lowers your risk of getting an infection in the hospital. You are less likely to get sick from a germ that is very hard to treat.

6. youtube.com youtube.com/watch?v=QEvT0sPz-Jg

The role and importance of chlorhexidine gluconate chlorexidine gluconate or chg is a key ingredient within antimicrobial skin cleansers offering effective protection.

7. youtube.com youtube.com/watch?v=kmsNS-bQuWw

CHG Skin Prep Wipes - 3-Day Instructions Skin bacteria are the most common cause of infections after surgery. Preparing or “prepping” skin at home just before surgery can reduce the ...

8. bd.com bd.com/en-us/products-and-solutions/products/product-brands/chloraprep

BD ChloraPrep™ Patient Preoperative Skin Preparation ... data) have been published, revealing positive outcomes related to the use of chlorhexidine gluconate (CHG)-based antiseptics. There are over 60+ published ...