drugset / Trial / NCT05401292

Skin Preparation for Elective Foot and Ankle Surgery

NCT05401292

Phase 4 Recruiting 100 enrolled University of Missouri-Columbia
RandomizedParallel-groupDouble-blindOther

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.

Timeline

Start
2022-02-15
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Isopropyl alcohol Other / unclassified 70 % Topical
Comparator Chlorhexidine gluconate Other / unclassified Topical

Indications

No indication recorded.