Chlorhexidine for Infection Prevention
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byMeghan F Davis, DVM, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Johns Hopkins Bloomberg School of Public Health
Disqualifiers: Chlorhexidine sensitivity, Dog allergy
No Placebo Group
Prior Safety Data
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of this trial?Hospital-based Animal-Assisted visitation programs are important complementary therapies, but concerns with infection control may challenge the sustainability of these programs. Pilot data suggest that a low-cost chlorhexidine-based intervention targeted to the dogs involved in the visitation programs holds high potential to prevent pathogen transmission during sessions. In this study, the following aims will be tested: 1) To identify program-related risk factors for acquisition of hospital-associated pathogens by pediatric patients during animal-assisted intervention (AAI) sessions during an initial run-in phase of no intervention; 2) To determine the effect of chlorhexidine (CHX)-based interventions on acquisition of hospital-associated pathogens and microbial communities by patients during AAI sessions via a multicenter randomized controlled trial; and 3) To determine whether the specific benefits achieved by the visitation program, i.e. reduction in blood pressure, heart rate and self-reported pain and anxiety, are impacted by the interventions.
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 drug Chlorhexidine for infection prevention?
Research shows that using chlorhexidine as a mouthwash after tooth extraction significantly reduces the risk of developing alveolar osteitis (a painful condition after tooth removal) by 63%. Additionally, chlorhexidine has been effective in reducing harmful bacteria in the mouth, which can help prevent infections during surgical procedures.
12345Is chlorhexidine safe for use in humans?
Chlorhexidine is generally safe for use in humans, but it can cause severe eye and ear toxicity if used improperly. In studies, it has been used safely in mouthwash and gel forms without reported adverse effects.
35678How does chlorhexidine differ from other treatments for infection prevention?
Chlorhexidine is unique because it is often used as a rinse or topical antiseptic to reduce harmful bacteria in the mouth or on the skin before procedures, which can help prevent infections. It is particularly effective against bacteria like Staphylococcus aureus and is often combined with alcohol for enhanced antimicrobial activity.
236910Eligibility Criteria
This trial is for children aged 3-17 cleared by a doctor to join hospital-based animal-assisted visitation sessions. It's not for kids who are allergic to dogs or sensitive to chlorhexidine, which is used in the study.Inclusion Criteria
My doctor has approved me to join a hospital program that includes visits from dogs.
My child is between 3 and 17 years old.
Exclusion Criteria
I am allergic to chlorhexidine products.
Children who are allergic or sensitive to dogs or substances found in dogs.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Run-in Phase
Identify program-related risk factors for acquisition of hospital-associated pathogens by pediatric patients during animal-assisted intervention sessions with no intervention
4 sessions
4 visits (in-person)
Treatment
Determine the effect of chlorhexidine-based interventions on acquisition of hospital-associated pathogens and microbial communities by patients during animal-assisted intervention sessions
8 sessions
8 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if using chlorhexidine on dogs can prevent them from transmitting pathogens like MRSA and Pseudomonas during therapy visits with hospitalized children. The trial will also see if this affects the program's benefits like reducing pain and anxiety.
3Treatment groups
Experimental Treatment
Active Control
Group I: CHX Intervention BExperimental Treatment1 Intervention
Dog-handler teams will follow a modified protocol for infection control, with Treatment B first for four sessions, and cross-over to Treatment A for four sessions. Participants enrolled in the session will derive their Arm assignment from the dog-handler team with which they interact.
Treatment B will consist of the same pre-session shampoo with a commercial veterinary chlorhexidine-based product (2-4% chlorhexidine), with a single wipe with a chlorhexidine-impregnated cloth (2-4% chlorhexidine) at arrival. This treatment will depend on the residual activity of chlorhexidine throughout the visit.
Group II: CHX Intervention AExperimental Treatment1 Intervention
Dog-handler teams will follow a modified protocol for infection control, with Treatment A first for four sessions, and cross-over to Treatment B for four sessions. Participants enrolled in the session will derive their Arm assignment from the dog-handler team with which they interact.
Treatment A consists of a pre-session shampoo with a commercial veterinary chlorhexidine-based product (2-4% chlorhexidine) within 24 hours prior to the session, and wiping with a chlorhexidine-impregnated cloth (2-4% chlorhexidine) at arrival at the session and every 20 minutes during the session, or between participants if the flow of participants is structured in a way that allows this (such as visits from one room to the next to visit individual patients).
Group III: ControlActive Control1 Intervention
Dog-handler teams will follow established hospital and therapy dog program guidelines for infection control with no changes for eight sessions. Participants enrolled in the session will derive their Arm assignment from the dog-handler team with which they interact.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns HopkinsBaltimore, MD
Washington University in St. LouisSaint Louis, MO
Children's Hospital of PhiladelphiaPhiladelphia, PA
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Who Is Running the Clinical Trial?
Johns Hopkins Bloomberg School of Public HealthLead Sponsor
University of PennsylvaniaCollaborator
Children's Hospital of PhiladelphiaCollaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
Clinical and microbiological effects of adjunctive, locally delivered chlorhexidine on patients with chronic periodontitis. [2013]The impact of a locally delivered chlorhexidine chip (Periochip) on clinical and microbiological parameters of chronic periodontitis requires further documentation. The aim of the present study was to investigate the effects of the chip as an adjunct to mechanical treatment of chronic periodontitis.
Reduction of salivary S. aureus and mutans group streptococci by a preprocedural chlorhexidine rinse and maximal inhibitory dilutions of chlorhexidine and cetylpyridinium. [2013]Staphylococcus aureus and mutans group streptococci can cause, among many other diseases, infective endocarditis and postoperative infections. The reduction of the number of these microorganisms in the oral cavity prior to surgical procedures has been related to a decreased incidence of such occurrences. The aim of this study was to evaluate the effect of a single preprocedural rinse with 0.12% chlorhexidine solution (Periogard) on the salivary counts of S aureus and mutans group streptococci and determine maximal inhibitory dilutions (MID) of this and 0.05% cetylpyridinium chloride solution (Cepacol).
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.
Antimicrobial activity of antiseptic-coated orthopaedic devices. [2019]Antimicrobial coating of medical devices, including fracture fixation devices, has evolved as a potentially effective method for preventing device-related infections. We examined the in vitro antimicrobial activity of titanium cylinders coated with the antiseptic combination of chlorhexidine and chloroxylenol. The coated devices provided zones of inhibition against Staphylococcus epidermidis, S. aureus, Pseudomonas aeruginosa, Escherichia coli and Candida albicans, at baseline and up to 8 weeks after incubation of the coated cylinders in human serum at 37 degrees C. This durable antimicrobial activity was attributed to the relatively slow leaching of chlorhexidine and chloroxylenol from the coated cylinders as measured by high-performance liquid chromatography. These results suggest that antiseptic-coated orthopaedic devices may provide broad-spectrum and durable antimicrobial protection against device-related infection.
Chlorhexidine for prevention of alveolar osteitis: a randomised clinical trial. [2018]Objective To determine the effectiveness of chlorhexidine 0.12% mouthwash (CHX) after tooth extraction for the prevention of alveolar osteitis (AO). Material and methods We conducted a double-blind randomised clinical trial stratified by risk factors. We enrolled a cohort of 822 patients who underwent dental extractions, and were considered to be at risk of developing AO (previous surgical site infection, traumatic extraction, and tobacco smoking). After extraction, patients were randomly allocated for CHX group or placebo group, matched by risk factors. The primary outcome was clinical diagnosis of AO: increasing postoperative pain for 4 d within and around the socket, and total or partial breakdown of the blood clot in the socket with or without bone exposure. Results Follow-up was completed by 744 participants (372 chlorhexidine and 372 placebo). We detected no significant differences between the two groups at baseline. After completed follow-up, risk factors were equally distributed between the two groups. Overall incidence of OA was 4.97%, in which 27 participants treated with placebo (7.26%) and 10 participants treated with CHX (2.69%) developed AO. CHX reduced the incidence of AO by 63% [Absolute Risk Reduction: 4.57 (95% CI 1.5-7.7), Number Needed to Treat: 21.88 (95% CI 13.0-69.3), Fisher's exact test: p=0.006]. No adverse effects were reported. Conclusion The use of chlorhexidine 0.12% mouthwash after tooth extraction is safe and effective in reducing the incidence of AO in high-risk patients.
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.
Repeated delivery of chlorhexidine chips for the treatment of peri-implantitis: A multicenter, randomized, comparative clinical trial. [2021]Peri-implantitis is a challenging condition to manage and is frequently treated using non-surgical debridement. The local delivery of antimicrobial agents has demonstrated benefit in mild to moderate cases of peri-implantitis. This study compared the safety and efficacy of chlorhexidine gluconate 2.5 mg chip (CHX chips) as an adjunctive treatment to subgingival debridement in patients afflicted with peri-implantitis.
A single application of chlorhexidine gel reduces gingival inflammation and interleukin 1-β following one-stage implant placement: A randomized controlled study. [2021]Chlorhexidine (CHX) is a broad-spectrum antimicrobial agent commonly used in medicine. Application of (CHX) during abutment connection reduced the bacterial load at the implant-abutment interface. We hypothesize this treatment may consequently reduce peri-implant soft tissue inflammation and marginal bone loss.
Maximum inhibitory dilution of mouthwashes containing chlorhexidine and polyhexamethylene biguanide against salivary Staphylococcus aureus. [2022]The aim of the present study was to determine the in vitro maximum inhibitory dilution (MID) of two chlorhexidinebased oral mouthwashes (CHX): Noplak, Periogard, and one polyhexamethylene biguanide-based mouthwash (PHMB): Sanifill Premium against 28 field Staphylococcus aureus strains using the agar dilution method.
The effect of different root canal medicaments on the elimination of Enterococcus faecalis ex vivo. [2021]The aim of this study was to evaluate the antimicrobial effect of chlorhexidine gel (CHX-G) 2%, chlorhexidine powder (CHX-P) 1%, povidone-iodine (PVP-I), polyhexanide and camphorated-and-mentholated chlorophenol (ChKM) ex vivo.