Skin Preparation for Elective Foot and Ankle Surgery

Surgical site infections (SSIs) make about 31% of all nosocomial infections and they are the most common hospital-acquired infection. For foot and ankle elective interventions, SSI rate is reported between 0.4% and 3.6%. This study will investigate the effectiveness of skin cleaning with isopropyl alcohol and scrubbing with chlorhexidine soap before standard skin preparation in reducing microbial load and surgical site infections for elective foot and ankle surgeries. Current standard of care includes skin preparation with iodine or chlorhexidine solution prior to sterile draping and the start of surgery. Standard of care will be applied to all patients. The use of an additional "pre-scrub" with isopropyl alcohol and scrubbing with chlorhexidine soap will be applied to the experimental group. The control group will receive only the standard of care skin preparation with iodine or chlorhexidine solution prior to draping.

Study Overview

• Status: Recruiting
• Conditions: Microbial Colonization; Foot and Ankle Disorders
• Intervention / Treatment: Drug: Hibiclens; Drug: Isopropyl Alcohol 70% Topical Application Solution

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Stacee Baker, MEd, BSN, RN; Phone Number: 5738849017; Email: staceebaker@health.missouri.edu
• Study Contact Backup: Name: Kyle Schweser, MD

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65211
      • Recruiting
      • University of Missouri
      • Contact: Stacee Baker, MEd, BSN, RN; Phone Number: 573-884-9017; Email: staceebaker@health.missouri.edu
      • Principal Investigator: Kyle Schweser, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients undergoing elective foot and ankle surgeries
• age over 18

Exclusion Criteria:

• trauma as the indication for surgery
• open injuries
• non-elective procedures
• amputations
• prior surgical site infection through the planned incision
• pregnancy. All potential participants of child-bearing potential follow the standard pre-operative protocol to ensure they are not in pregnant status prior to SOC surgical procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Iodine or Chlorhexidine Preparation; Standard of care with only skin preparation of iodine or chlorhexidine solution prior to sterile draping before surgery.	Drug: Hibiclens; antiseptic/antimicrobial skin cleanser for skin wound and general skin cleansing
Active Comparator: Iodine or Chlorhexidine Scrub Brush Pre-Scrub with Isopropyl Alcohol and Chlorhexidine Soap; In addition to standard of care skin preparation with iodine or chlorhexidine solution prior to sterile draping, patients will also receive an additional "pre-scrub" with isopropyl alcohol and chlorhexidine soap. The operative extremity will be scrubbed for 2 minutes with chlorhexidine soap with a scrub brush until the entire extremity is covered. Isopropyl alcohol will then be wiped onto the skin with a gauze and allowed to evaporate (dry).	Drug: Hibiclens; antiseptic/antimicrobial skin cleanser for skin wound and general skin cleansing; Drug: Isopropyl Alcohol 70% Topical Application Solution; First aid antiseptic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Site Infection	rate of surgical site infection (SSI) and wound complications following skin preparation for surgery. Measured by the number of surgical site infections in the total population of patients in the cohort	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbial Load	effectiveness of reducing microbial load. Comparing original microbial load to final microbial load (CFU/g)	90 days

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Chlorhexidine gluconate
• Other Study ID Numbers: 2074962

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No