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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

Dilute Betadine Soak and Scrub for Foot and Ankle Surgery

Clinicaltrials.gov identifier NCT03926208

Recruitment Status Completed

First Posted April 24, 2019

Last update posted September 1, 2020

Study Description

Brief summary:

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.

  • Condition or Disease:Postoperative Infection
    Postoperative Complications
  • Intervention/Treatment: Procedure: Soak and Scrub
    Procedure: Clorihexadine scrub
  • Phase: N/A
Detailed Description

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 chlorihexadine 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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 242 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: One group will be randomized to receive a betadine soak and scrub (in addition to the standard of care) prior to surgery. The control group will receive the standard of care.
  • Masking: None (Open Label) ()
  • Primary Purpose: Prevention
  • Official Title: Randomized Trial of Dilute Betadine Soak and Scrub for Foot and Ankle Surgery
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: December 2019
  • Actual Study Completion Date: January 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Soak and Scrub
In addition to the standard chlorihexadine prep of the foot prior to surgery, subjects in this group will also receive a betadine soak and scrub of the foot, and a cotton swab will be collected from the hallux nail fold.
Procedure: Soak and Scrub
Betadine soak and scrub in addition to standard clorihexadine scrub (standard of care).
Active Comparator: Control
Subjects in this group will receive the standard chlorihexadine prep of the foot (standard of care) prior to surgery, and a cotton swab will be collected from the hallux nail fold.
Procedure: Clorihexadine scrub
Clorihexadine scrub (standard of care).
Outcome Measures
  • Primary Outcome Measures: 1. Culture [ Time Frame: 1 day ]
    Cotton swab of hallux nail fold. Culture of any microorganisms found.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

1. ≥ 18 years of age

2. Patient requires a foot or ankle operative procedure

3. Patient provides informed consent

Exclusion Criteria:

1. Patient refuses

2. Patient is incarcerated, incapacitated, or otherwise unable to provide appropriate
informed consent

Contacts and Locations
Contacts
Locations

United States, Illinois
Rush University Medical Center
Chicago

Sponsors and Collaborators

Rush University Medical Center

American Orthopaedic Foot & Ankle Society

Investigators

Principal Investigator: Kamran S Hamid, MD Rush University Medical Center

More Information