Clinical trial NCT03926208: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Infection
Postoperative Complications
Keywords: Betadine
Foot
Ankle
Nail fold
Scrub
Infection
Prevention
Postoperative
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Bacterial Culture Growth
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Kamran S Hamid, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.