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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether the pressure used during a shoulder wash with ChloraPrep, a skin cleaner containing Chlorhexidine Gluconate, affects its effectiveness in removing C. acnes bacteria. One shoulder will receive a gentle wipe, while the other will undergo a firmer, massage-like pressure. Researchers will assess the bacteria levels on the skin an hour later. This trial is suitable for English speakers without very sensitive skin, allergies to the cleaner, recent antibiotic or acne treatment use, or shoulder wounds. As an unphased trial, it offers participants the chance to contribute to understanding the effectiveness of different cleaning techniques.

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 prior data suggests that this method is safe for infection prevention in shoulder surgery?

Research has shown that chlorhexidine gluconate is safe and effective for cleaning skin before surgery. Studies have found it prevents infections and is twice as effective as another common antiseptic, povidone iodine. Chlorhexidine gluconate has been widely used in surgeries without major safety concerns, making it a trusted choice for reducing bacteria on the skin during medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using chlorhexidine gluconate for infection prevention in shoulder surgery because it offers a targeted approach to reducing surgical site infections. Unlike traditional options that might rely on systemic antibiotics, chlorhexidine gluconate is a topical antiseptic that directly targets bacteria on the skin, potentially lowering the chance of infections more effectively. This method is appealing because it could lead to fewer side effects and decreased antibiotic resistance, making surgeries safer and recovery quicker.

What evidence suggests that this method is effective for reducing C. acnes in shoulder surgery?

Research has shown that chlorhexidine gluconate, the main ingredient in ChloraPrep, effectively reduces bacteria on the skin. Studies have found that ChloraPrep outperforms povidone-iodine in eliminating certain bacteria, such as coagulase-negative Staphylococcus, often found in areas where shoulder surgeries occur. One study discovered that using 2% chlorhexidine cloths before shoulder surgery reduced skin bacteria. This trial will evaluate chlorhexidine gluconate's effectiveness in reducing skin bacteria, crucial for preventing infections during surgeries. Participants will be assigned to different treatment arms, with one shoulder receiving the test treatment and the other serving as a control. ^{1 2 6 7 8}

Who Is on the Research Team?

Jason Hsu, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

Citations

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pmc.ncbi.nlm.nih.gov

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Infection prevention strategies in shoulder surgery

randomized 150 shoulder surgery patients to receive either Chloraprep (2% chlorhexidine gluconate and 70% isopropyl alcohol), Duraprep (0.7 ...

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sciencedirect.com

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Impact of postoperative skin disinfection with chlorhexidine ...

Our study could not confirm that postoperative disinfection with chlorhexidine reduces bacterial colonisation compared with sodium chloride.

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pubmed.ncbi.nlm.nih.gov

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Efficacy of surgical preparation solutions in shoulder surgery

ChloraPrep and DuraPrep were more effective than povidone-iodine in eliminating coagulase-negative Staphylococcus from the shoulder region (p < 0.001 for both).

4.

thelancet.com

thelancet.com/journals/lanmic/article/PIIS2666-5247(22)00187-2/fulltext

Efficacy of different preoperative skin antiseptics on ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1058274611000930

Efficacy of preoperative home use of 2% chlorhexidine ...

The use of the 2% chlorhexidine cloth was effective at decreasing overall bacterial culture rates before shoulder surgery and was particularly effective at ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9720868/

Evaluation of the effectiveness of skin preparation methods ...

Nine studies evaluated skin preparation methods used as home treatment prior to shoulder surgery. Eight assessed the effectiveness of benzoyl peroxide (BPO)28, ...

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ajicjournal.org

ajicjournal.org/article/S0196-6553(13)00008-4/fulltext

Does chlorhexidine gluconate provide a risk reduction ...

Evidence-based clinical studies have shown chlorhexidine gluconate to be a safe and effective perioperative skin-prepping agent.

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Optimizing Outcomes in Shoulder Arthroplasty

The risk of developing a healthcare associated infection (HAI) in patients undergoing surgery has been documented at 2.8 per 100 surgeries, with ...