Skin Preparation for Elective Foot and Ankle Surgery

Part of paid clinical trials in Columbia, Missouri.

Sponsor
University of Missouri-Columbia
Study ID
NCT05401292
Phase
PHASE4
Status
Recruiting
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Conditions

  • Foot and Ankle Disorders
  • Microbial Colonization

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hibiclens — DRUG
    antiseptic/antimicrobial skin cleanser for skin wound and general skin cleansing
  • Isopropyl Alcohol 70% Topical Application Solution — DRUG
    First aid antiseptic

Study Details

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.

Key Dates

Start date
Feb 15, 2022
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Iodine or Chlorhexidine Preparation
    Standard of care with only skin preparation of iodine or chlorhexidine solution prior to sterile draping before surgery.
  • Active Comparator: Iodine or Chlorhexidine Scrub Brush Pre-Scrub with Isopropyl Alcohol and Chlorhexidine Soap
    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).

Primary Outcome Measure

Surgical Site Infection [ Time Frame: 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MissouriColumbiaMissouri65211
Vicki Jones, MEd, CCRP
[email protected]
573-882-7583
Kyle Schweser, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Missouri· Columbia, MO

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