Dilute Betadine Soak and Scrub for Foot and Ankle Surgery

NCT03926208 | Completed Results

• 1 other identifier: 18021801-IRB02
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Infection; Postoperative Complications

Keywords

Betadine; Foot; Ankle; Nail fold; Scrub; Infection; Prevention; Postoperative

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Study Arms (2)

Control

ACTIVE COMPARATOR

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.

Procedure: Clorhexadine scrub

Soak and Scrub

EXPERIMENTAL

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.

Procedure: Soak and Scrub

Interventions

Soak and Scrub PROCEDURE

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

Soak and Scrub

Clorhexadine scrub PROCEDURE

Clorhexadine scrub (standard of care).

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (7)

• 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.

  PMID: 20497730 BACKGROUND

• 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.

  PMID: 11603664 BACKGROUND

• 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.

  PMID: 27416219 BACKGROUND

• 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.

  PMID: 26678427 BACKGROUND

• 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.

  PMID: 15866959 BACKGROUND

• 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.

  PMID: 8603978 BACKGROUND

• 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.

  PMID: 23653955 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications; Infections

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Daniel D. Bohl
• Organization: Rush University Medical Center

danielbohl@gmail.com

414.640.7245

Study Officials

• Kamran S Hamid, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, M.D. MPH

Model Details: 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.

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 24, 2019
• Study Start: May 24, 2019
• Primary Completion: December 10, 2019
• Study Completion: January 1, 2020
• Last Updated: February 12, 2021
• Results First Posted: February 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)