Rush University Medical Center
Chicago, Illinois, 60612, United States
NCT Number: NCT03926208
Infection and wound complications are the most common complications following orthopaedic foot and ankle procedures, and the infection rate following these procedures is higher than in procedures involving other areas of the body.The purpose of this randomized controlled trial is to determine whether a standard chlorhexidine prep can be augmented with a soak & scrub of the foot in dilute betadine to reduce the rate of positive cultures from the hallux nail fold prior to surgery.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60612, United States
Infection and wound complications are the most common complications following orthopaedic foot and ankle procedures, and the infection rate following these procedures is higher than in procedures involving other areas of the body. This is at least in part because the anatomy of the human foot presents inherent challenges for preoperative sterilization techniques due to the many folds and crevices associated with the toes. In particular, the nail folds of the toes are known to harbor large amounts of bacteria.
A systematic review and meta-analysis of previous studies that have investigated the efficacy of various foot and ankle preparation agents (including alcohol, chlorhexidine, chloroxylenol, and iodine/iodophors) showed that no single agent or combination of agents eliminates positive culture growth to undetectable levels for all patients. Articles have suggested superiority of a chlorhexidine prep solution over other types of preps; hence, chlorhexidine prep is now considered the gold standard at many institutions. But even a chlorhexidine prepped foot has been shown to contain culturable bacteria in the nail folds in 30% of cases.
The purpose of this randomized controlled trial is to determine whether a standard chlorhexidine prep can be augmented with a soak & scrub in dilute betadine to reduce the rate of positive cultures from the hallux nail fold.
It is hypothesized that in comparison to feet receiving the standard chlorhexadine prep, feet receiving the standard prep plus the betadine soak & scrub will be less likely to have culture positive swabs of the hallux nail fold.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Betadine soak and scrub in addition to standard clorhexadine scrub (standard of care).
Clorhexadine scrub (standard of care).
Time frame: 1 day
Cotton swab of hallux nail fold. Culture of any microorganisms found. The results indicate the number of patients with positive bacterial culture growth.
Rush University Medical Center
Other
Randomized Trial of Dilute Betadine Soak and Scrub for Foot and Ankle Surgery
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