Education Video for Reducing Infections

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

1000 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment CHG Skin Treatment Video in reducing infections?

Research shows that chlorhexidine gluconate (CHG), a key component of the treatment, is effective in reducing bacterial density on the skin and decreasing infections, including those associated with medical devices. Studies have demonstrated that CHG baths can lower the risk of acquiring multidrug-resistant organisms and catheter-associated bloodstream infections. ^{1 2 3 4 5}

Is the CHG Skin Treatment Video generally safe for humans?

Chlorhexidine gluconate (CHG) is generally considered safe for use as a skin antiseptic in adults and children, but it may cause severe eye and ear irritation. It is not recommended for use in preterm infants due to limited safety data. ^{1 6 7 8 9}

How does the CHG Skin Treatment Video differ from other treatments for reducing infections?

The CHG Skin Treatment Video is unique because it uses chlorhexidine gluconate (CHG), a topical antiseptic, to reduce bacterial density on the skin, which is effective in preventing healthcare-associated infections and colonization with multi-resistant organisms. Unlike some other antiseptics, CHG has been shown to have immediate, persistent, and cumulative antimicrobial effects, making it particularly effective for preoperative skin preparation and reducing the risk of infections in clinical settings. ^{1 4 5 8 10}

What is the purpose of this trial?

Chlorhexidine gluconate (CHG) bathing is an effective intervention to reduce hospitalized patient's risk of acquiring a central line-associated bloodstream infection (CLABSI). While daily CHG bathing for hospitalized patients is widely supported in the literature, patient adherence with this practice is suboptimal. Written and verbal information is provided to patients by nursing staff regarding the importance of CHG bathing and the correct usage of the CHG cloths; however, these methods can be hindered by literacy and language barriers. Medical videos have become popular avenues to provide necessary education to patients, and have been shown to improve patient-reported outcomes. Whereas the benefits of educational videos has been described in previous studies on advanced care planning and postoperative quality of life, they have not been described for CHG bathing. In this study, we aim to provide education (including the rationale/importance of CHG bathing, and the appropriate process for bathing) through the use of a short video provided to hospitalized patients. The purpose of this study is to evaluate the use of medical videos to educate patients on CHG bathing while hospitalized in the inpatient setting.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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) 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

0.01% Hypochlorous Acid as an Alternative Skin Antiseptic: An In Vitro Comparison. [2019]

3. Netherlands 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. [2020]

4. New Zealand pubmed.ncbi.nlm.nih.gov

The effects of daily chlorhexidine bathing on cutaneous bacterial isolates: a pilot study. [2021]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Differential Effects of Chlorhexidine Skin Cleansing Methods on Residual Chlorhexidine Skin Concentrations and Bacterial Recovery. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Estimated Methicillin-Resistant Staphylococcus aureus Decolonization in Intensive Care Units Associated With Single-Application Chlorhexidine Gluconate or Mupirocin. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Safety of chlorhexidine gluconate used for skin antisepsis in the preterm infant. [2013]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

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