Chlorhexidine Gluconate for Infection Prevention in Shoulder Surgery

Overseen By Anastasia Whitson

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Antibiotics, Acne treatments

Disqualifiers: Sensitive skin, Chlorhexidine allergy, Wounds, others

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: 1

Duration: 1 day

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used antibiotics or acne treatments in the last three months.

What data supports the effectiveness of the treatment Chlorhexidine Gluconate for infection prevention in shoulder surgery?

Research shows that using chlorhexidine gluconate before shoulder surgery can lower the amount of bacteria on the skin, which may help reduce the risk of infection. However, it may not be effective against all types of bacteria, such as Cutibacterium, which is commonly found on the skin. ^{1 2 3 4 5}

Is Chlorhexidine Gluconate safe for use in humans?

Chlorhexidine Gluconate has been used as a topical antiseptic for over 50 years and is generally considered safe for use in surgical procedures, although it can cause severe eye and ear irritation if not used properly. ^{3 4 5 6 7}

How does the drug Chlorhexidine Gluconate differ from other treatments for infection prevention in shoulder surgery?

Chlorhexidine Gluconate is unique because it is an antiseptic that is effective against a wide range of bacteria, viruses, and fungi, and is used preoperatively to reduce skin bacteria levels. However, it is not effective against Cutibacterium, a common bacteria in shoulder surgeries, and can cause skin irritation or burns in some cases. ^{1 2 4 8 9}

What is the purpose of this trial?

The goal of this interventional study is to determine the amount of skin C. acnes reduction with increased pressure during the chlorhexidine gluconate, brand name ChloraPrep, application. The main question it aims to answer is: Does changing the pressure applied during the ChloraPrep application impact the amount of C. acnes bacteria on the skin after one hour? Researchers will compare ChloraPrep applied at a pressure similar to a gentle wipe to ChloraPrep applied at a pressure similar to a massage to see if wash the amount of C. acnes on the skin after one hour is different. Participants will have one shoulder washed with ChloraPrep using pressure meant to impact the dermal layer, similar to a gentle wipe, and the other shoulder washed with ChloraPrep using pressure meant to impact the subdermal layer, similar to a massage. Participants will have swabs taken of their skin before the ChloraPrep application and again one hour after application to look for the amount of C. acnes on the skin.

Research Team

Jason Hsu, MD

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for individuals preparing for shoulder replacement surgery who are not currently experiencing infections. The study aims to prevent post-surgical joint infections by optimizing skin cleaning methods before the operation.

Inclusion Criteria

English speaking

Exclusion Criteria

Self report very sensitive skin

Allergic to chlorhexidine

Used antibiotics in the last three months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive ChloraPrep application with varying pressure on each shoulder to assess C. acnes reduction

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Chlorhexidine Gluconate

Trial Overview The study tests whether applying Chlorhexidine Gluconate (ChloraPrep) with different pressures affects the reduction of C. acnes bacteria on the skin. One shoulder will be cleaned with gentle pressure, and the other with firmer massage-like pressure.

Participant Groups

Group I: Randomization Option 2 Experimental Treatment 1 Intervention

Right shoulder, Control Group ; Left shoulder, Test Group

Group II: Randomization Option 1 Experimental Treatment 1 Intervention

Right shoulder, Test Group ; Left shoulder, Control Group

Chlorhexidine Gluconate is already approved in United States, Canada, European Union 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 Canada as Chlorhexidine Gluconate for:

• Skin disinfection before surgery
• Wound cleaning
• Preventing dental plaque
• Treating yeast infections of the mouth

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

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Findings from Research

In a study of 100 patients undergoing shoulder surgery, using 2% chlorhexidine gluconate cloths before surgery significantly reduced the rate of pathogenic bacteria on the skin compared to standard soap and water, with positive culture rates of 66% versus 94%.

The chlorhexidine cloths were particularly effective against coagulase-negative Staphylococcus, which is a common cause of postoperative infections, suggesting that this method could enhance infection prevention strategies without leading to any infections in the two-month follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of preoperative home use of 2% chlorhexidine gluconate cloth before shoulder surgery. Murray, MR., Saltzman, MD., Gryzlo, SM., et al.[2022]

In a study of 66 patients undergoing shoulder arthroplasty, pre-operative chlorhexidine showers effectively reduced the skin load of various bacterial species, but did not significantly decrease the load of Cutibacterium, which is a major contributor to shoulder infections.

The findings suggest that while chlorhexidine showers can help lower some bacterial counts, they are not effective against Cutibacterium, indicating a need for alternative methods to better manage this specific bacteria before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

While home chlorhexidine washes prior to shoulder surgery lower skin loads of most bacteria, they are not effective against Cutibacterium (Propionibacterium). Matsen, FA., Whitson, AJ., Hsu, JE.[2021]

ChloraPrep™ significantly reduces the time required for surgical site skin preparation in total hip arthroplasty, averaging 3.5 minutes compared to 13.5 minutes for Betadine®, which can enhance operating room efficiency.

The cost of using ChloraPrep™ for skin preparation is substantially lower, averaging €46.8 per patient compared to €155 for Betadine®, indicating potential health economic benefits alongside its recognized effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical solutions for preoperative skin preparation in total hip arthroplasty: A cost-effectiveness analysis of Betadine® and Chloraprep™. Rougereau, G., Chatelain, L., Terracher, R., et al.[2022]

Bactisure, a recently FDA-approved topical adjuvant, showed the most significant reduction in biofilm formation of Staphylococcus aureus, Staphylococcus epidermidis, and Cutibacterium acnes on various orthopedic implant metals, indicating its potential effectiveness in treating periprosthetic joint infections.

All tested topical adjuvants, including povidone-iodine and chlorhexidine gluconate, significantly reduced biofilm formation compared to controls, demonstrating that these agents can effectively combat bacterial adherence on orthopedic implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of topical adjuvants in reducing biofilm formation on orthopedic implants: an in vitro analysis. Kia, C., Cusano, A., Messina, J., et al.[2021]

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]

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]

Chlorhexidine gluconate (CHG) is a safe and effective antiseptic for perioperative skin preparation, with studies showing it can significantly reduce microbial skin burden, including harmful bacteria like methicillin-resistant Staphylococcus aureus.

Recent research indicates that using 0.05% CHG for wound irrigation before closure can lead to a greater than 5-log reduction in harmful pathogens, suggesting it may effectively lower the risk of postoperative surgical site infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing the risk of surgical site infections: does chlorhexidine gluconate provide a risk reduction benefit? Edmiston, CE., Bruden, B., Rucinski, MC., et al.[2013]

Chlorhexidine, while effective as an antiseptic, was associated with superficial partial thickness burns in three patients after shoulder arthroscopic surgery, indicating a potential risk when used for skin preparation.

The burns were likely caused by a combination of chlorhexidine application, local swelling from the surgery, and traction, leading to pain, erythema, and blistering, although all cases resolved within three months with some scarring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chlorhexidine burns after shoulder arthroscopy. Sanders, TH., Hawken, SM.[2013]

In a study involving 50 male patients undergoing shoulder arthroplasty, both chlorhexidine washes and benzoyl peroxide soap were ineffective in reducing Cutibacterium levels on the skin surface and in the dermis, with 100% positivity in both groups.

The bacterial load measured on the skin surface and the incised dermal edge was similar for both treatments, indicating that neither method significantly impacted the presence of Cutibacterium before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of chlorhexidine wash versus benzoyl peroxide soap for home surgical preparation: neither is effective in removing Cutibacterium from the skin of shoulder arthroplasty patients. Hsu, JE., Whitson, AJ., Woodhead, BM., et al.[2021]

References

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

Efficacy of preoperative home use of 2% chlorhexidine gluconate cloth before shoulder surgery. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

While home chlorhexidine washes prior to shoulder surgery lower skin loads of most bacteria, they are not effective against Cutibacterium (Propionibacterium). [2021]

3. France pubmed.ncbi.nlm.nih.gov

Surgical solutions for preoperative skin preparation in total hip arthroplasty: A cost-effectiveness analysis of Betadine® and Chloraprep™. [2022]

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

Effectiveness of topical adjuvants in reducing biofilm formation on orthopedic implants: an in vitro analysis. [2021]

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

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

Reducing the risk of surgical site infections: does chlorhexidine gluconate provide a risk reduction benefit? [2013]

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

Chlorhexidine burns after shoulder arthroscopy. [2013]

9. Germany pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of chlorhexidine wash versus benzoyl peroxide soap for home surgical preparation: neither is effective in removing Cutibacterium from the skin of shoulder arthroplasty patients. [2021]