Skin Preparation for Foot and Ankle Surgery

Overseen By Vicki L Jones, MEd, CCRP

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Missouri-Columbia

Disqualifiers: Trauma, Open injuries, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for cleaning the skin before foot and ankle surgeries to determine if it reduces infection risk. Researchers aim to discover whether an additional scrub with isopropyl alcohol and chlorhexidine soap (Hibiclens) makes a difference. One group will receive this extra cleaning step, while the other will use the usual method with iodine or chlorhexidine. Individuals scheduled for foot and ankle surgeries without open injuries may be suitable for this study. As a Phase 4 trial, this research explores how an FDA-approved and effective treatment can benefit more 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's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for the treatments used in this trial?

Research has shown that cleaning the skin with a mix of isopropyl alcohol and chlorhexidine soap before surgery is generally safe. Studies have found that using chlorhexidine with alcohol effectively reduces skin bacteria and is commonly used in hospitals. One study found that this combination lowered the risk of infections at the surgery site compared to other methods. Clinical studies have also confirmed that chlorhexidine gluconate, a key component of the soap, is safe and effective for pre-surgery skin cleaning. Overall, these findings suggest that this method is well-tolerated with few safety concerns. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores new approaches to skin preparation for foot and ankle surgery, which is crucial for preventing infections. Standard care usually involves using iodine or chlorhexidine solutions alone. However, this trial investigates an additional pre-scrub technique using isopropyl alcohol and chlorhexidine soap. This method involves scrubbing the operative area with a chlorhexidine soap brush for two minutes, followed by an isopropyl alcohol wipe, which could potentially enhance skin disinfection. By comparing these methods, researchers hope to find out if the additional pre-scrub step offers better results in reducing surgical site infections, which could lead to improved patient outcomes.

What evidence suggests that this skin preparation method is effective for reducing surgical site infections in foot and ankle surgeries?

This trial will compare different skin preparation methods for foot and ankle surgery. Research has shown that cleaning the skin with a mix of isopropyl alcohol and chlorhexidine soap before surgery effectively reduces bacteria. One study found this combination works better than other solutions, like iodine, in preventing infections at the surgery site. Another study showed it significantly removes bacteria from the skin, which is important for reducing these infections. Early evidence suggests that using 2% chlorhexidine with 70% alcohol is especially effective in surgeries involving bones and joints, such as foot and ankle operations. This method is effective and long-lasting, with only rare cases of skin irritation. Participants in this trial may receive either the standard iodine or chlorhexidine preparation or an additional pre-scrub with isopropyl alcohol and chlorhexidine soap. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 years old who are scheduled for elective foot and ankle surgeries. It's not suitable for those with trauma-related surgery, non-elective procedures, pregnant individuals, prior infections at the surgical site, open injuries, or amputations.

Inclusion Criteria

I am scheduled for elective foot or ankle surgery.

I am over 18 years old.

Exclusion Criteria

My surgery is due to an injury.

I have had an infection in a previous surgery area.

I am not pregnant or have confirmed it following the standard protocol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo skin preparation with iodine or chlorhexidine solution, with an additional pre-scrub for the experimental group

1 day

1 visit (in-person)

Follow-up

Participants are monitored for surgical site infections and microbial load reduction

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Hibiclens
• Isopropyl Alcohol 70% Topical Application Solution

Trial Overview The study tests if additional skin cleaning with isopropyl alcohol and chlorhexidine soap before standard iodine or chlorhexidine preparation can reduce microbial load and prevent infections in elective foot and ankle surgeries.

How Is the Trial Designed?

Group I: Iodine or Chlorhexidine Preparation Active Control 1 Intervention

Standard of care with only skin preparation of iodine or chlorhexidine solution prior to sterile draping before surgery.

Group II: Iodine or Chlorhexidine Scrub Brush Pre-Scrub with Isopropyl Alcohol and Chlorhexidine Soap Active Control 2 Interventions

In addition to standard of care skin preparation with iodine or chlorhexidine solution prior to sterile draping, patients will also receive an additional "pre-scrub" with isopropyl alcohol and chlorhexidine soap. The operative extremity will be scrubbed for 2 minutes with chlorhexidine soap with a scrub brush until the entire extremity is covered. Isopropyl alcohol will then be wiped onto the skin with a gauze and allowed to evaporate (dry).

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Published Research Related to This Trial

In a study of 49 patients undergoing foot or ankle surgery, standard surgical preparation with chlorhexidine and povidone-iodine did not achieve a completely sterile field, as 35% of patients still had positive cultures for normal aerobic bacteria.

Adding 70% alcohol to the standard preparation did not significantly reduce the rate of bacterial contamination, indicating that it may not provide additional benefits in preventing surgical site contamination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Residual bacterial contamination after surgical preparation of the foot or ankle with or without alcohol. Hort, KR., DeOrio, JK.[2017]

In a study involving 154 obstetric patients, both Hibiclens and Hibitane Tincture demonstrated over 99% bacterial kill rates on skin bacteria within 10 and 30 minutes of application, indicating their strong antimicrobial efficacy.

Hibitane Tincture caused vulvar irritation due to its high isopropanol content, making it unsuitable as a perigenital antiseptic, while Hibiclens showed no side effects and is considered a promising antiseptic for obstetric and gynecologic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antimicrobial effect of chlorhexidine on bacteria of groin, perineum and vagina. Vorherr, H., Ulrich, JA., Messer, RH., et al.[2013]

The antiseptics containing 4% chlorhexidine gluconate and isopropyl alcohol effectively inactivated HIV within 15 seconds, demonstrating rapid efficacy against the virus.

Using these antiseptics undiluted for hand disinfection after contact with HIV-contaminated materials or for cleaning cuts can provide significant protection against HIV transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective inactivation of human immunodeficiency virus with chlorhexidine antiseptics containing detergents and alcohol. Montefiori, DC., Robinson, WE., Modliszewski, A., et al.[2019]

A systematic review of 106 studies found that using chlorhexidine gluconate-alcohol (CHG-alcohol) at concentrations of 0.5% and 2.0% significantly reduces the risk of surgical site infections (SSI) compared to povidone-iodine (PVP-I).

No significant difference in SSI rates was observed with CHG-alcohol concentrations above 2.0%, suggesting that higher concentrations may not provide additional benefits for surgical skin preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of surgical skin preparation with chlorhexidine in alcohol according to the concentration required to prevent surgical site infection: meta-analysis. Hasegawa, T., Tashiro, S., Mihara, T., et al.[2022]

Accidental exposure to Hibiclens (chlorhexidine 4% and detergent) can lead to severe and permanent corneal opacification, as seen in two patients.

Experimental studies on rabbit eyes showed that exposure to Hibiclens for just 5 to 15 minutes caused severe, irreversible corneal damage in all cases, highlighting its high toxicity to corneal tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hibiclens keratitis. Hamed, LM., Ellis, FD., Boudreault, G., et al.[2019]

In a study involving 127 patients undergoing clean elective foot and ankle surgery, chlorhexidine scrub combined with isopropyl alcohol paint significantly reduced bacterial contamination compared to povidone-iodine, with only 38% of patients in the chlorhexidine group showing positive cultures versus 79% in the povidone-iodine group.

The results suggest that chlorhexidine and alcohol are more effective surgical preparatory agents for reducing local flora on the feet, leading to a recommendation for their use in foot and ankle surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chlorhexidine provides superior skin decontamination in foot and ankle surgery: a prospective randomized study. Bibbo, C., Patel, DV., Gehrmann, RM., et al.[2019]

In a study of 95 patients undergoing foot and ankle surgery, using isopropyl alcohol followed by chlorhexidine for skin preparation resulted in a lower rate of positive bacterial cultures compared to the reverse order, suggesting a more effective method for reducing bacterial load before surgery.

Despite the differences in bacterial culture results, both preparation methods led to low postoperative infection rates, with only one infection in each group within 30 days, indicating that both methods are safe and effective for surgical site preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, Prospective Study of the Order of Preoperative Preparation Solutions for Patients Undergoing Foot and Ankle Orthopedic Surgery. Hunter, JG., Dawson, LK., Soin, SP., et al.[2017]

A review of literature suggests that a combined chlorhexidine and alcohol preparation technique may be the most effective for reducing surgical site infections (SSIs) in orthopedic foot and ankle surgeries, although evidence is mixed.

Current studies primarily rely on skin swab cultures to assess antiseptic effectiveness, indicating a need for higher-quality research with larger populations and more relevant clinical outcomes to establish definitive guidelines for preoperative skin antisepsis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin Preparation Techniques for Orthopedic Foot and Ankle Surgery: A Current Concepts Review. Mehraban, N., Holmes, GB., Lin, 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]

Using isopropyl alcohol significantly reduces bacterial cultures on the skin and nails before foot and ankle surgery, especially when combined with a bristled brush for scrubbing, leading to a reduction in positive cultures from 76% to 12%.

The study demonstrated that the combination of isopropyl alcohol and a bristled brush is the most effective skin-preparation technique, outperforming traditional methods using soft sponges, which showed only limited benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative skin preparation of the foot and ankle: bristles and alcohol are better. Keblish, DJ., Zurakowski, D., Wilson, MG., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9487656/

Efficacy of surgical skin preparation with chlorhexidine in ... This meta-analysis is the first study that clarifies the usefulness of an alcohol-based CHG solution with a 0.5 per cent or higher CHG concentration for ...

2. researchgate.net researchgate.net/publication/309713446_EFFICACY_OF_SURGICAL_PREPARATION_SOLUTIONS_IN_FOOT_AND_ANKLE_SURGERY

EFFICACY OF SURGICAL PREPARATION SOLUTIONS IN ... However, a prospective, randomised, nonblinded study revealed a superiority of 2% chlorhexidine combined with 70% isopropyl alcohol versus 10% ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15866959/

Efficacy of surgical preparation solutions in foot and ankle ... Of the three solutions tested in the present study, the combination of chlorhexidine and alcohol (ChloraPrep) was most effective for eliminating bacteria from ...

4. 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

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

5. sciencedirect.com sciencedirect.com/science/article/pii/S0195670122002717

Antimicrobial persistence of two alcoholic preoperative skin ... CHG+IPA and PVP-I+IPA were both found to be effective, persistent antiseptic skin preparations. Overall, skin irritation was uncommon.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7914441/

Randomised Controlled Trials of Alcohol-Based Surgical Site ... (4) Conclusions: The use of chlorhexidine-alcohol skin preparations was associated with a reduced risk of SSI compared to iodophor-alcohol ...

7. 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.

8. journalofhospitalinfection.com journalofhospitalinfection.com/article/S0195-6701(22)00271-7/fulltext

Antimicrobial persistence of two alcoholic preoperative skin ... A clinical study comparing the skin antisepsis and safety of ChloraPrep, 70% isopropyl alcohol, and 2% aqueous chlorhexidine. J Infus Nurs ...