Dilute Betadine Soak and Scrub for Foot and Ankle Surgery
Primary Purpose
Postoperative Infection, Postoperative Complications
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Soak and Scrub
Clorhexadine scrub
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Infection focused on measuring Betadine, Foot, Ankle, Nail fold, Scrub, Infection, Prevention, Postoperative
Eligibility Criteria
Inclusion Criteria:
- β₯ 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
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Soak and Scrub
Arm Description
Subjects in this group will receive the standard chlorhexadine prep of the foot (standard of care) prior to surgery, and a cotton swab will be collected from the hallux nail fold.
In addition to the standard chlorhexadine 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.
Outcomes
Primary Outcome Measures
Bacterial Culture Growth
Cotton swab of hallux nail fold. Culture of any microorganisms found. The results indicate the number of patients with positive bacterial culture growth.
Secondary Outcome Measures
Full Information
NCT ID
NCT03926208
First Posted
April 22, 2019
Last Updated
January 25, 2021
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03926208
Brief Title
Dilute Betadine Soak and Scrub for Foot and Ankle Surgery
Official Title
Randomized Trial of Dilute Betadine Soak and Scrub for Foot and Ankle Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 24, 2019 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Infection, Postoperative Complications
Keywords
Betadine, Foot, Ankle, Nail fold, Scrub, Infection, Prevention, Postoperative
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
242 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Subjects in this group will receive the standard chlorhexadine prep of the foot (standard of care) prior to surgery, and a cotton swab will be collected from the hallux nail fold.
Arm Title
Soak and Scrub
Arm Type
Experimental
Arm Description
In addition to the standard chlorhexadine 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.
Intervention Type
Procedure
Intervention Name(s)
Soak and Scrub
Intervention Description
Betadine soak and scrub in addition to standard clorhexadine scrub (standard of care).
Intervention Type
Procedure
Intervention Name(s)
Clorhexadine scrub
Intervention Description
Clorhexadine scrub (standard of care).
Primary Outcome Measure Information:
Title
Bacterial Culture Growth
Description
Cotton swab of hallux nail fold. Culture of any microorganisms found. The results indicate the number of patients with positive bacterial culture growth.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
β₯ 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamran S Hamid, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be made available to other researchers.
Citations:
PubMed Identifier
20497730
Citation
Butterworth P, Gilheany MF, Tinley P. Postoperative infection rates in foot and ankle surgery: a clinical audit of Australian podiatric surgeons, January to December 2007. Aust Health Rev. 2010 May;34(2):180-5. doi: 10.1071/AH08687.
Results Reference
background
PubMed Identifier
11603664
Citation
Donley BG, Philbin T, Tomford JW, Sferra JJ. Foot and ankle infections after surgery. Clin Orthop Relat Res. 2001 Oct;(391):162-70. doi: 10.1097/00003086-200110000-00017.
Results Reference
background
PubMed Identifier
27416219
Citation
Physiology for Nursing Practice Physiology for Nursing Practice edited by Hinchcliff S Montague S Published by Bailliere Tindall 680pp pound9.95 0-7020-1194-0 [Formula: see text]. Nurs Stand. 1988 May 21;2(33):34. doi: 10.7748/ns.2.33.34.s62.
Results Reference
background
PubMed Identifier
26678427
Citation
Hunter JG, Dawson LK, Soin SP, Baumhauer JF. Randomized, Prospective Study of the Order of Preoperative Preparation Solutions for Patients Undergoing Foot and Ankle Orthopedic Surgery. Foot Ankle Int. 2016 May;37(5):478-82. doi: 10.1177/1071100715623037. Epub 2015 Dec 17.
Results Reference
background
PubMed Identifier
15866959
Citation
Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005 May;87(5):980-5. doi: 10.2106/JBJS.D.01977.
Results Reference
background
PubMed Identifier
8603978
Citation
Sands K, Vineyard G, Platt R. Surgical site infections occurring after hospital discharge. J Infect Dis. 1996 Apr;173(4):963-70. doi: 10.1093/infdis/173.4.963.
Results Reference
background
PubMed Identifier
23653955
Citation
Yammine K, Harvey A. Efficacy of preparation solutions and cleansing techniques on contamination of the skin in foot and ankle surgery: A systematic review and meta-analysis. Bone Joint J. 2013 Apr;95-B(4):498-503. doi: 10.1302/0301-620X.95B4.30893.
Results Reference
background
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Dilute Betadine Soak and Scrub for Foot and Ankle Surgery
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