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OpenTrials
Completed

NCT Number: NCT03926208

Dilute Betadine Soak and Scrub for Foot and Ankle Surgery

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥ 18 years of age
  • Patient requires a foot or ankle operative procedure
  • Patient provides informed consent

Exclusion criteria

  • Patient refuses
  • Patient is incarcerated, incapacitated, or otherwise unable to provide appropriate informed consent

Treatment and study plan

Soak and Scrub

Procedure

Betadine soak and scrub in addition to standard clorhexadine scrub (standard of care).

Clorhexadine scrub

Procedure

Clorhexadine scrub (standard of care).

Primary outcomes

  1. Bacterial Culture Growth

    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.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

Randomized Trial of Dilute Betadine Soak and Scrub for Foot and Ankle Surgery

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 24, 2019
Registry last updated
Feb 12, 2021

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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