Chlorhexidine for Infection Prevention

Recruiting at 2 trial locations

Overseen By Kaitlin Waite, DVM

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Chlorhexidine sensitivity, Dog allergy

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 8 sessions

412 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{2 3 6 7 8}

How 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. ^{1 2 6 9 10}

Research Team

Meghan F Davis, DVM, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility 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.

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

Treatment Details

Interventions

• Chlorhexidine

Trial Overview 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.

Participant Groups

Group I: CHX Intervention B Experimental Treatment 1 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 A Experimental Treatment 1 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: Control Active Control 1 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.

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

A single preprocedural rinse with 0.12% chlorhexidine significantly reduced salivary counts of Staphylococcus aureus and mutans group streptococci by over 99%, indicating its efficacy in minimizing infection risk before surgical procedures.

Chlorhexidine remains effective at a dilution of 1:80, suggesting that even lower concentrations can still provide safety benefits for patients undergoing invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of salivary S. aureus and mutans group streptococci by a preprocedural chlorhexidine rinse and maximal inhibitory dilutions of chlorhexidine and cetylpyridinium. de Albuquerque, RF., Head, TW., Mian, H., et al.[2013]

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 822 patients at risk for alveolar osteitis (AO) after tooth extraction, chlorhexidine 0.12% mouthwash significantly reduced the incidence of AO by 63%, with only 2.69% of patients developing AO compared to 7.26% in the placebo group.

The study found no adverse effects associated with chlorhexidine use, confirming its safety and efficacy for preventing AO in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chlorhexidine for prevention of alveolar osteitis: a randomised clinical trial. Halabi, D., Escobar, J., Alvarado, C., et al.[2018]

In a study involving 50 patients with chronic periodontitis, the addition of a chlorhexidine chip (Periochip) to standard scaling and root planing did not result in a significant reduction in probing depth compared to scaling and root planing alone over six months.

Both treatment groups showed improvements in clinical indices, but the differences were not statistically significant, indicating that the chlorhexidine chip may not provide additional benefits in managing chronic periodontitis when used as a single administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and microbiological effects of adjunctive, locally delivered chlorhexidine on patients with chronic periodontitis. Sakellari, D., Ioannidis, I., Antoniadou, M., et al.[2013]

Titanium cylinders coated with a combination of chlorhexidine and chloroxylenol showed effective antimicrobial activity against various pathogens, including Staphylococcus and E. coli, lasting up to 8 weeks after being incubated in human serum.

The sustained antimicrobial effect is due to the slow release of the antiseptics from the coating, indicating that these coated orthopedic devices could significantly reduce the risk of infections related to medical implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antimicrobial activity of antiseptic-coated orthopaedic devices. Darouiche, RO., Green, G., Mansouri, MD.[2019]

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 of 290 patients with peri-implantitis, the use of chlorhexidine gluconate chips as an adjunct to subgingival debridement resulted in a significant reduction in implant pocket depth (IPD) compared to the control group, with a mean reduction of 1.76 mm versus 1.54 mm at 24 weeks.

The treatment was well tolerated with no severe adverse events, and younger patients under 65 and non-smokers showed particularly better responses to the chlorhexidine chip treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeated delivery of chlorhexidine chips for the treatment of peri-implantitis: A multicenter, randomized, comparative clinical trial. Machtei, EE., Romanos, G., Kang, P., et al.[2021]

In a study involving 40 patients, the application of 1% chlorhexidine gel during dental implant procedures significantly reduced gingival inflammation, as indicated by lower gingival index scores at both 1 week and 3 months compared to the control group.

The use of chlorhexidine gel also correlated with lower levels of interleukin 1-β, a marker of inflammation, suggesting that this treatment may help manage peri-implant soft tissue health effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single application of chlorhexidine gel reduces gingival inflammation and interleukin 1-β following one-stage implant placement: A randomized controlled study. Asbi, T., Hussein, HA., Horwitz, J., et al.[2021]

Chlorhexidine-based mouthwashes (Noplak and Periogard) demonstrated superior antimicrobial activity against Staphylococcus aureus strains compared to the polyhexamethylene biguanide-based mouthwash (Sanifill Premium), with Noplak and Periogard inhibiting all strains at a dilution of 1/320.

Sanifill Premium was the least effective, only inhibiting all strains at a higher dilution of 1/40, indicating that CHX-based mouthwashes are more effective options for oral antimicrobial use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximum inhibitory dilution of mouthwashes containing chlorhexidine and polyhexamethylene biguanide against salivary Staphylococcus aureus. Nascimento, AP., Tanomaru, JM., Matoba-Júnior, F., et al.[2022]

Chlorhexidine gel (CHX-G) 2% and chlorhexidine powder (CHX-P) 1% were found to be highly effective in eliminating Enterococcus faecalis from root canal samples, outperforming povidone-iodine (PVP-I) and polyhexanide.

Both CHX-G and CHX-P demonstrated better biocompatibility compared to camphorated-and-mentholated chlorophenol (ChKM), making them preferable choices for root canal treatment based on their antimicrobial efficacy and safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of different root canal medicaments on the elimination of Enterococcus faecalis ex vivo. Dammaschke, T., Jung, N., Harks, I., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Reduction of salivary S. aureus and mutans group streptococci by a preprocedural chlorhexidine rinse and maximal inhibitory dilutions of chlorhexidine and cetylpyridinium. [2013]

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

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

3. Brazil pubmed.ncbi.nlm.nih.gov

Chlorhexidine for prevention of alveolar osteitis: a randomised clinical trial. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Clinical and microbiological effects of adjunctive, locally delivered chlorhexidine on patients with chronic periodontitis. [2013]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Antimicrobial activity of antiseptic-coated orthopaedic devices. [2019]

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

Repeated delivery of chlorhexidine chips for the treatment of peri-implantitis: A multicenter, randomized, comparative clinical trial. [2021]

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

A single application of chlorhexidine gel reduces gingival inflammation and interleukin 1-β following one-stage implant placement: A randomized controlled study. [2021]

9. Brazil pubmed.ncbi.nlm.nih.gov

Maximum inhibitory dilution of mouthwashes containing chlorhexidine and polyhexamethylene biguanide against salivary Staphylococcus aureus. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

The effect of different root canal medicaments on the elimination of Enterococcus faecalis ex vivo. [2021]