Antiseptic Skin Preparation for Joint Replacement Surgery

(CLEANJoint Trial)

Recruiting at 3 trial locations

Overseen By Erin Lillie, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Prosthetic joint infection, Allergy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two antiseptic solutions to determine which better prevents infections during hip or knee replacement surgeries. Participants will use either a chlorhexidine gluconate-alcohol solution or a povidone-iodine solution to clean their skin before surgery. The goal is to identify which solution reduces the likelihood of needing another surgery due to infection or wound issues within a year. Individuals scheduled for a hip or knee replacement and without current infections may be suitable candidates. Participants will complete two short surveys after surgery to help gather necessary data. As an unphased trial, this study allows participants to contribute to important research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on skin preparation solutions for surgery.

What prior data suggests that these skin preparation solutions are safe for joint replacement surgery?

Research has shown that both chlorhexidine gluconate-alcohol solution and povidone-iodine solution are safe antiseptics for surgery. Studies have found that chlorhexidine solutions, particularly those with a 4%-5% concentration, effectively reduce infections during surgeries. Other research confirms that a 2% chlorhexidine solution mixed with 70% alcohol lowers infection risk and reduces skin bacteria.

For povidone-iodine, studies highlight its safety and effectiveness in preventing infections. Specifically, using a diluted povidone-iodine solution during surgery has decreased the risk of germs and infections.

Both solutions appear safe based on past research. Participants in clinical studies have generally tolerated them well without major issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring two common antiseptic solutions—Chlorhexidine Gluconate-Alcohol and Povidone-Iodine—used in preparing skin for joint replacement surgery. Both solutions are known for their ability to eliminate harmful bacteria and reduce infection risk, but the trial aims to find out which might be more effective in this specific surgical context. While these solutions are already widely used, the trial could provide valuable insights into optimizing infection prevention during surgery. By comparing these antiseptics head-to-head, researchers hope to identify the best practice, potentially leading to improved surgical outcomes and patient safety.

What evidence suggests that this trial's skin preparation solutions could be effective for preventing infections in joint replacement surgery?

This trial will compare the effectiveness of chlorhexidine gluconate-alcohol solution and povidone-iodine solution in reducing skin bacteria before joint replacement surgery, which helps prevent infections. Research has shown that chlorhexidine can lower bacteria levels during surgery, reducing the risk of infection afterward. It significantly reduces infections at the surgery site in joint replacements like knee and hip surgeries. Similarly, povidone-iodine is effective and safe for preventing joint infections when used to prepare the skin. Studies have found no major difference between these solutions in preventing infections in joint surgeries, making both good options for reducing complications after surgery. Participants in this trial will receive one of these antiseptic solutions as part of their surgical preparation. ^{1 6 7 8 9}

Who Is on the Research Team?

Raman Mundi, MD MSc FRCSC

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who are scheduled to have revision surgery on a hip or knee replacement where at least one artificial joint part will be swapped out. It's not suitable for those with conditions that might interfere with the study.

Inclusion Criteria

I am scheduled for a hip or knee replacement revision.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo revision arthroplasty surgery with either chlorhexidine gluconate-alcohol solution or povidone-iodine solution for skin preparation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for re-operation, wound complications, and infection of the prosthetic joint. Surveys are conducted at 30 days and 1 year post-surgery.

1 year

2 visits (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Chlorhexidine Gluconate-Alcohol Solution
• Povidone-Iodine Solution

Trial Overview The study compares two antiseptic solutions used during surgery: chlorhexidine gluconate-alcohol and povidone-iodine, to see which is better at preventing infections after hip or knee replacement revisions. Participants will be randomly assigned to a solution and surveyed twice post-surgery.

How Is the Trial Designed?

Group I: Chlorhexidine gluconate-alcohol solution Active Control 1 Intervention

Chlorhexidine gluconate-alcohol solution is a type of solution that has antiseptic properties, which means it helps to eliminate harmful bacteria on the skin at the time of surgery, and therefore, reduce the risk of infection.

Group II: Povidone-iodine solution Active Control 1 Intervention

Povidone-iodine solution is a type of solution that has antiseptic properties, which means it helps to eliminate harmful bacteria on the skin at the time of surgery, and therefore, reduce the risk of infection.

Chlorhexidine Gluconate-Alcohol Solution is already approved in European Union, United States, Canada, Switzerland for the following indications:

Approved in European Union as Chlorhexidine Gluconate-Alcohol Solution for:

• Surgical skin preparation
• Prevention of surgical site infections

Approved in United States as Chlorhexidine Gluconate-Alcohol Solution for:

• Surgical skin preparation
• Prevention of surgical site infections

Approved in Canada as Chlorhexidine Gluconate-Alcohol Solution for:

• Surgical skin preparation
• Prevention of surgical site infections

Approved in Switzerland as Chlorhexidine Gluconate-Alcohol Solution for:

• Surgical skin preparation
• Prevention of surgical site infections

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Published Research Related to This Trial

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]

The study found that both 1% chlorhexidine-gluconate/61% ethanol (CHG/Ethanol) emollient and 7.5% povidone-iodine (PVI) scrub had similar antimicrobial effects, with no significant difference in the number of microorganisms present immediately after surgical scrubs and after operations.

However, CHG/Ethanol emollient was associated with better skin condition and higher satisfaction among users compared to PVI, suggesting it may be a preferable option for surgical scrubs in terms of user comfort and skin health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of a waterless, scrubless chlorhexidine gluconate/ethanol surgical scrub and povidone-iodine for antimicrobial efficacy]. Choi, JS.[2019]

Both Povidone iodine with isopropyl alcohol (PVP-I+IPA) and Iodine Povacrylex+IPA showed strong antimicrobial activity, effectively reducing microbial populations by 99.99% in time-kill tests at various contact times, indicating their efficacy in preventing healthcare-associated infections.

In a clinical study, both antiseptic solutions met FDA efficacy requirements for antimicrobial activity on skin, demonstrating safety with no adverse events, thus supporting their use in preoperative skin preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antimicrobial performance of two preoperative skin preparation solutions containing iodine and isopropyl alcohol. Bashir, MH., Hollingsworth, A., Thompson, JD., et al.[2022]

This pilot study successfully demonstrated the feasibility of a cluster randomized crossover trial to compare the effectiveness of 10% povidone-iodine and 4% chlorhexidine gluconate solutions in preventing surgical site infections in orthopedic trauma patients.

Out of 135 enrolled patients, the study achieved a high compliance rate of 98% and 100% accurate documentation of surgical site infections, indicating that the trial design is robust and ready for a definitive study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solution in open fractures (Aqueous-PREP): the feasibility of a cluster randomized crossover study. Sprague, S., Guyatt, P., Bzovsky, S., et al.[2021]

In a study of 351 patients undergoing clean-contaminated upper abdominal surgeries, chlorhexidine-gluconate skin preparation resulted in a lower incidence of surgical site infections (SSIs) at 10.8% compared to 17.9% for povidone iodine, suggesting it may be a more effective option.

While the overall results were not statistically significant, chlorhexidine showed a significant reduction in SSIs during the first postoperative week (7% vs. 14.1% for povidone iodine, P = 0.03), indicating a potential benefit in early postoperative infection prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy of chlorhexidine gluconate versus povidone iodine as preoperative skin preparation for the prevention of surgical site infections in clean-contaminated upper abdominal surgeries. Srinivas, A., Kaman, L., Raj, P., et al.[2018]

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]

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 of 1,476 cardiac surgery patients, both 2% chlorhexidine-alcohol and 10% povidone-iodine-alcohol skin preparations showed similar overall rates of surgical site infections (SSI), with rates of 3.3% and 3.8% respectively.

However, the 10% povidone-iodine-alcohol preparation was found to be marginally more effective in reducing organ-space infections, suggesting it may offer a slight advantage in that specific area without significantly improving the prevention of incisional SSIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of choice of skin preparation solution in cardiac surgery on rate of surgical site infection: a propensity score matched analysis. Raja, SG., Rochon, M., Mullins, C., et al.[2022]

Povidone-iodine (PI) was found to be highly effective, killing all tested bacteria immediately upon contact, making it a strong candidate for preventing infections during joint surgeries.

Chlorhexidine gluconate (CHG) and vancomycin (VANC) showed variable effectiveness, with CHG failing to kill certain bacteria at short exposure times, while VANC required longer exposure (18-20 hours) to be effective against MRSA and Staphylococcus epidermidis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Intraoperative Antiseptic Techniques in the Prevention of Periprosthetic Joint Infection: Superiority of Betadine. Cichos, KH., Andrews, RM., Wolschendorf, F., et al.[2020]

A meta-analysis of 11 randomized controlled trials involving 12,072 participants found that alcohol-based chlorhexidine gluconate (CHG) significantly reduces the risk of surgical site infections (SSIs) compared to aqueous-based povidone-iodine (PVI) in abdominal surgeries, with an odds ratio of 0.84.

The findings suggest that using alcohol-based CHG as a skin antiseptic before abdominal surgery may be more effective in preventing SSIs, potentially influencing clinical practice guidelines for surgical preparations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol-Containing Versus Aqueous-Based Solutions for Skin Preparation in Abdominal Surgery: A Systematic Review and Meta-analysis. Peristeri, DV., Nour, HM., Ahsan, A., et al.[2023]

Citations

1. cureus.com cureus.com/articles/416077-efficacy-of-generic-2-chlorhexidine-gluconate-in-70-alcohol-versus-chloraprep-for-preventing-surgical-site-infections-in-orthopedic-surgery-a-scoping-review.pdf?email=

Efficacy of Generic 2% Chlorhexidine Gluconate in 70% ... Generic/unbranded formulations of 2% chlorhexidine gluconate in 70% isopropyl alcohol have been demonstrated to be as effective as ChloraPrep ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5423571/

Use of Chlorhexidine Preparations in Total Joint Arthroplasty Chlorhexidine can be left on the hands, and it will continue to lower bacterial counts during the procedure 52.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12576735/

Effectiveness of surgical skin preparation solutions in ... No significant difference was found between iodine and chlorhexidine-based solutions in total joint arthroplasty, spine surgery, foot and ankle surgery, or ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1743919117301267

Review Preoperative chlorhexidine reduces the incidence ... The present meta-analysis indicated that preadmission chlorhexidine protocol was an effective way to reduce surgical site infection in total knee and hip ...

5. journals.lww.com journals.lww.com/international-journal-of-surgery/fulltext/2024/11000/evaluation_of_the_efficacy_of.48.aspx

Evaluation of the efficacy of chlorhexidine-alcohol vs.... It may be inferred that preoperative skin cleansing using chlorhexidine reduces the occurrence of postoperative surgical site infections (SSIs).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5712016/

Intraoperative chlorhexidine irrigation to prevent infection ... The purpose of this study was to evaluate the effect of chlorhexidine gluconate (CHG) irrigation on infection rates following THA and TKA.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1877056822001827

Surgical solutions for preoperative skin preparation in total ... The purpose of our study was to compare the cost of surgical site skin preparation using ChloraPrep™ (2% chlorhexidine gluconate [CHG] and 70% isopropyl ...

8. journals.lww.com journals.lww.com/annalsofsurgery/fulltext/2021/12000/the_comparative_efficacy_of_chlorhexidine.36.aspx

The Comparative Efficacy of Chlorhexidine Gluconate and... Conclusions: Alcoholic formulations of 4%–5% CHG seem to be safe and twice as effective as PVI (alcoholic or aqueous solutions) in preventing infection after ...

9. researchgate.net researchgate.net/publication/396213785_Efficacy_of_Generic_2_Chlorhexidine_Gluconate_in_70_Alcohol_versus_ChloraPrep_for_Preventing_Surgical_Site_Infections_in_Orthopaedic_Surgery_A_Scoping_Review

(PDF) Efficacy of Generic 2% Chlorhexidine Gluconate in ... Early evidence suggests generic 2% chlorhexidine in 70% alcohol may effectively reduce infection and bacterial load in orthopaedic surgery.