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Dilute Betadine Soak and Scrub for Foot and Ankle Surgery

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ClinicalTrials.gov Identifier: NCT03926208
Recruitment Status : Completed
First Posted : April 24, 2019
Last Update Posted : September 1, 2020
Sponsor:
Collaborator:
American Orthopaedic Foot & Ankle Society
Information provided by (Responsible Party):
Kamran S Hamid, MD, Rush University Medical Center

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 Intervention/treatment Phase
Postoperative Infection Postoperative Complications Procedure: Soak and Scrub Procedure: Clorihexadine scrub Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 24, 2019
Actual Primary Completion Date : December 10, 2019
Actual Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
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).

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).




Primary Outcome Measures :
  1. Culture [ Time Frame: 1 day ]
    Cotton swab of hallux nail fold. Culture of any microorganisms found.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926208


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
American Orthopaedic Foot & Ankle Society
Investigators
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Principal Investigator: Kamran S Hamid, MD Rush University Medical Center
Publications:
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Responsible Party: Kamran S Hamid, MD, Principle Investigator, M.D. MPH, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03926208    
Other Study ID Numbers: 18021801-IRB02
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be made available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kamran S Hamid, MD, Rush University Medical Center:
Betadine
Foot
Ankle
Nail fold
Scrub
Infection
Prevention
Postoperative
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes
Benzalkonium Compounds
Benzethonium
Anti-Infective Agents, Local
Anti-Infective Agents