Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID05401292

Skin Preparation for Elective Foot and Ankle Surgery

Led by University of Missouri-Columbia · Updated on 2026-04-27

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Surgical site infections are a common problem in hospitals, especially after foot and ankle surgeries, where infection rates range from 0.4% to 3.6%. This research aims to evaluate whether adding a "pre-scrub" with isopropyl alcohol and chlorhexidine soap before the usual skin preparation can reduce microbial presence and surgical site infections. The study is a Phase 4 randomized trial sponsored by the University of Missouri-Columbia. Participants will be randomly assigned to one of two groups. The control group will have the standard skin preparation using iodine or chlorhexidine solution before surgery. The experimental group will receive this usual preparation plus an additional two-minute scrub of the limb with chlorhexidine soap and isopropyl alcohol applied and allowed to dry before sterile draping. During the study, participants will be monitored for 90 days after surgery to track surgical site infections and microbial load on the skin. Researchers will collect data on infection rates and bacterial presence to assess the effectiveness of the additional pre-scrub. This study includes adult patients undergoing elective foot and ankle surgeries, with follow-up visits or assessments scheduled as needed for safety and outcome measurements.

CONDITIONS

Brief Title

Skin Preparation for Elective Foot and Ankle Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing elective foot and ankle surgeries
  • Age over 18 years
Not Eligible

You will not qualify if you...

  • Surgery due to trauma
  • Open injuries
  • Non-elective procedures
  • Amputations
  • Prior surgical site infection through the planned incision
  • Pregnancy; participants of child-bearing potential must follow standard pre-operative pregnancy testing protocols

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to day of surgery

Participants receive skin preparation with either iodine or chlorhexidine solution prior to surgery, with some also receiving an additional pre-scrub with isopropyl alcohol and chlorhexidine soap.

1 visit on the day of surgery (in-person)

Follow-up

Duration - 90 days

Participants are monitored for surgical site infection and microbial load after surgery.

Follow-up visits as per standard post-operative care

Trial Site Locations

Total: 1 location

1

University of Missouri

Columbia, Missouri, United States, 65211

Actively Recruiting

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Research Team

V

Vicki L Jones, MEd, CCRP

K

Kyle Schweser, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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