NCT05401292

Skin Preparation for Elective Foot and Ankle Surgery

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Microbial Colonization
• Foot and Ankle Disorders

Interventions

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

Timeline

• Start date: 2022-02-15
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-06-02
• Last updated: 2025-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study