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

Trial Summary

What is the purpose of this trial?

Surgical site infections (SSIs) make about 31% of all nosocomial infections and they are the most common hospital-acquired infection. For foot and ankle elective interventions, SSI rate is reported between 0.4% and 3.6%. This study will investigate the effectiveness of skin cleaning with isopropyl alcohol and scrubbing with chlorhexidine soap before standard skin preparation in reducing microbial load and surgical site infections for elective foot and ankle surgeries. Current standard of care includes skin preparation with iodine or chlorhexidine solution prior to sterile draping and the start of surgery. Standard of care will be applied to all patients. The use of an additional "pre-scrub" with isopropyl alcohol and scrubbing with chlorhexidine soap will be applied to the experimental group. The control group will receive only the standard of care skin preparation with iodine or chlorhexidine solution prior to draping.

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 data supports the effectiveness of the treatment Hibiclens, Chlorhexidine gluconate, and Isopropyl Alcohol 70% for skin preparation in foot and ankle surgery?

Research shows that using chlorhexidine and isopropyl alcohol together is more effective at reducing bacteria on the skin than using povidone-iodine, which suggests it can help prevent infections during foot and ankle surgery. ^{1 2 3 4 5}

Is the skin preparation for foot and ankle surgery using chlorhexidine and isopropyl alcohol safe?

Chlorhexidine and isopropyl alcohol are generally safe for skin preparation, but Hibiclens (a chlorhexidine product) can cause irritation if it comes into contact with sensitive areas like the eyes or genital region. In rare cases, it may cause a burning sensation when used vaginally. ^{1 6 7 8 9}

How does the skin preparation treatment for foot and ankle surgery differ from other treatments?

This treatment uses a combination of 4% chlorhexidine gluconate and 70% isopropyl alcohol, which has been shown to reduce bacterial loads more effectively than povidone-iodine, making it a superior option for preventing infections in foot and ankle surgeries. ^{1 2 3 4 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

References

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

Randomized, Prospective Study of the Order of Preoperative Preparation Solutions for Patients Undergoing Foot and Ankle Orthopedic Surgery. [2017]

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

Chlorhexidine provides superior skin decontamination in foot and ankle surgery: a prospective randomized study. [2019]

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

Preoperative skin preparation of the foot and ankle: bristles and alcohol are better. [2017]

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

Residual bacterial contamination after surgical preparation of the foot or ankle with or without alcohol. [2017]

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

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

6. England pubmed.ncbi.nlm.nih.gov

Effective inactivation of human immunodeficiency virus with chlorhexidine antiseptics containing detergents and alcohol. [2019]

7. England 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. [2022]

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

Hibiclens keratitis. [2019]

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

Antimicrobial effect of chlorhexidine on bacteria of groin, perineum and vagina. [2013]

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

Skin Preparation Techniques for Orthopedic Foot and Ankle Surgery: A Current Concepts Review. [2021]