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Skin Preparation for Foot and Ankle Surgery

Phase 4

Recruiting

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

patients undergoing elective foot and ankle surgeries

age over 18

Must not have

open injuries

trauma as the indication for surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

Drug Has Already Been Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial will compare the rate of surgical site infections in patients who receive a pre-scrub with isopropyl alcohol and chlorhexidine soap to those who only receive the standard of care skin preparation with iodine or chlorhexidine solution.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include skin irritation or allergic reactions to the antiseptic agents used (isopropyl alcohol or chlorhexidine). These could manifest as redness, itching, or rash at the application site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for elective foot or ankle surgery.

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have open wounds.

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My surgery is due to an injury.

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I have had an infection in a previous surgery area.

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I have not had any unplanned medical procedures.

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I have had an amputation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Surgical Site Infection

Secondary study objectives

Microbial Load

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Iodine or Chlorhexidine PreparationActive Control1 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 SoapActive Control2 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).

0 / 7Eligibility criteria met