Education Video for Reducing Infections
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Duke University
Disqualifiers: Chlorhexidine allergy, Comfort care
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
16789How 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.
145810Eligibility 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
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 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 GroupActive Control1 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:
馃嚭馃嚫 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
馃嚜馃嚭 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
馃嚚馃嚘 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Indiana University Health University HospitalIndianapolis, IN
Indiana University Health Methodist HospitalIndianapolis, IN
Duke University HospitalDurham, NC
WakeMed Health and HospitalsRaleigh, NC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
Advanced Care Planning DecisionsCollaborator
Massachusetts General HospitalCollaborator
Indiana University HealthCollaborator
References
Analyses comparing the antimicrobial activity and safety of current antiseptic agents: a review. [2019]This article reviews the results and conclusions from four pivotal and two comparative clinical trials. The six randomized, controlled, single-blinded, parallel-group clinical trials were conducted to determine which antiseptic is best for use as a patient preoperative skin preparation. The objective of these studies was to compare the immediate, persistent (residual), and cumulative antimicrobial efficacy and safety of 2% chlorhexidine gluconate (CHG) combined with 70% isopropyl alcohol (IPA) (ChloraPrep); another combination CHG and IPA antiseptic (CHG+IPA) and 2% aqueous CHG alone; 4% CHG (Hibiclens) alone; 70% isopropyl alcohol (IPA) alone; and an iodine-containing solution, 10% povidone-iodine (Betadine) alone as preoperative skin topical antiseptics for potential prevention of nosocomial infections.
0.01% Hypochlorous Acid as an Alternative Skin Antiseptic: An In Vitro Comparison. [2019]Compare the in vitro efficacy of hypochlorous acid 0.01% (HA), povidone iodine 5% (PI), chlorhexidine gluconate 4% (CHG), and isopropyl alcohol 70% (IPA) against common skin microorganisms.
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]Chlorhexidine gluconate (CHG) is routinely used for skin antisepsis before surgery. Its activity may be affected by formulation ingredients and the presence of organic matter such as blood and proteins. This in vitro study was designed to evaluate the antimicrobial activity of a new CHG skin prep containing a film-forming copolymer, and detect its potential for developing resistance and the potential for cross-resistance to antibiotics after CHG exposure.
The effects of daily chlorhexidine bathing on cutaneous bacterial isolates: a pilot study. [2021]Chlorhexidine gluconate (CHG) is a topical antiseptic used in a myriad of clinical settings. Recently, CHG baths have been shown to decrease multidrug-resistant organism acquisition and infections and catheter-associated bloodstream infections. The present study examined the effects of daily bathing with CHG on the recovery and antimicrobial susceptibility of cultivable cutaneous bacteria. The objectives of this study were to (1) explore the effects of clinical CHG bathing on cultivable cutaneous bacteria, (2) study the relationship between CHG minimum inhibitory concentration and antimicrobial susceptibility of coagulase-negative staphylococci, and (3) demonstrate the feasibility of the approach so a more definitive study may be performed. Significant decreases in bacterial colony counts and phenotypic diversity occurred with greater CHG exposure. The findings also suggest an inverse relationship between CHG minimum inhibitory concentration and antimicrobial susceptibility. Larger prospective studies are necessary to fully investigate the clinical impact of CHG usage.
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]The topical use of chlorhexidine gluconate (CHG) is intended to reduce bacterial density on patients' skin.
Review: Perspective on ocular toxicity of presurgical skin preparations utilizing Chlorhexidine Gluconate/Hibiclens/Chloraprep. [2022]Chlorhexidine Gluconate (CHG), Hibiclens (4% CHG with 4% Isopropyl Alcohol Detergent), and Chloraprep (i.e. labeled CHG-based solutions), utilized as preoperative surgical preparatory solutions may all cause severe oculotoxicity and ototoxicity. Alternatively, 10% Povidone-Iodine (PI) solutions without detergent demonstrate minimal toxic effects on the eyes and ears.
Differential Effects of Chlorhexidine Skin Cleansing Methods on Residual Chlorhexidine Skin Concentrations and Bacterial Recovery. [2021]BACKGROUND Bathing intensive care unit (ICU) patients with 2% chlorhexidine gluconate (CHG)-impregnated cloths decreases the risk of healthcare-associated bacteremia and multidrug-resistant organism transmission. Hospitals employ different methods of CHG bathing, and few studies have evaluated whether those methods yield comparable results. OBJECTIVE To determine whether 3 different CHG skin cleansing methods yield similar residual CHG concentrations and bacterial densities on skin. DESIGN Prospective, randomized 2-center study with blinded assessment. PARTICIPANTS AND SETTING Healthcare personnel in surgical ICUs at 2 tertiary-care teaching hospitals in Chicago, Illinois, and Boston, Massachusetts, from July 2015 to January 2016. INTERVENTION Cleansing skin of one forearm with no-rinse 2% CHG-impregnated polyester cloth (method A) versus 4% CHG liquid cleansing with rinsing on the contralateral arm, applied with either non-antiseptic-impregnated cellulose/polyester cloth (method B) or cotton washcloth dampened with sterile water (method C). RESULTS In total, 63 participants (126 forearms) received method A on 1 forearm (n=63). On the contralateral forearm, 33 participants received method B and 30 participants received method C. Immediately and 6 hours after cleansing, method A yielded the highest residual CHG concentrations (2500 碌g/mL and 1250 碌g/mL, respectively) and lowest bacterial densities compared to methods B or C (P
Estimated Methicillin-Resistant Staphylococcus aureus Decolonization in Intensive Care Units Associated With Single-Application Chlorhexidine Gluconate or Mupirocin. [2021]Chlorhexidine gluconate (CHG) and mupirocin are widely used to decolonize patients with methicillin-resistant Staphylococcus aureus (MRSA) and reduce risks associated with infection in hospitalized populations. Quantifying the association of an application of CHG alone or in combination with mupirocin with risk of MRSA infection is important for studies evaluating alternative decolonization strategies or schedules and for identifying whether there is room for improved decolonizing agents.
Safety of chlorhexidine gluconate used for skin antisepsis in the preterm infant. [2013]Chlorhexidine gluconate (CHG) is a widely used topical antiseptic that is recommended by the Centers for Disease Control and Prevention for skin cleansing before central venous catheter insertion in adults and children. Because of limited safety data, CHG is not recommended for use in children
[Evaluation of a waterless, scrubless chlorhexidine gluconate/ethanol surgical scrub and povidone-iodine for antimicrobial efficacy]. [2019]The purpose of this study was to compare 1% chlorhexidine-gluconate/61% ethanol (CHG/Ethanol) emollient and 7.5% povidone-iodine (PVI) scrub for antimicrobial,residual effect, and skin condition.