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Recruiting

NCT Number: NCT05401292

Skin Preparation for Elective Foot and Ankle Surgery

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.

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Key information

Conditions

Microbial Colonization Communicable Diseases Disease Attributes Foot and Ankle Disorders Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Missouri

Columbia, Missouri, 65211, United States

Location status: Recruiting

Location contact

Kyle Schweser, MD

PRINCIPAL_INVESTIGATOR

Vicki Jones, MEd, CCRP

CONTACT

[email protected]

573-882-7583

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing elective foot and ankle surgeries
  • age over 18

Exclusion criteria

  • trauma as the indication for surgery
  • open injuries
  • non-elective procedures
  • amputations
  • prior surgical site infection through the planned incision
  • pregnancy. All potential participants of child-bearing potential follow the standard pre-operative protocol to ensure they are not in pregnant status prior to SOC surgical procedure.

Treatment and study plan

Hibiclens

Drug

antiseptic/antimicrobial skin cleanser for skin wound and general skin cleansing

Isopropyl Alcohol 70% Topical Application Solution

Drug

First aid antiseptic

Primary outcomes

  1. Surgical Site Infection

    Time frame: 90 days

    rate of surgical site infection (SSI) and wound complications following skin preparation for surgery. Measured by the number of surgical site infections in the total population of patients in the cohort

Secondary outcomes

  1. Microbial Load

    Time frame: 90 days

    effectiveness of reducing microbial load. Comparing original microbial load to final microbial load (CFU/g)

Study contacts

Contact information is provided by the study sponsor or research team.

Kyle Schweser, MD

CONTACT

Vicki L Jones, MEd, CCRP

CONTACT

[email protected]

5738827583

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 2, 2022
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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