Skin Preparation for Elective Foot and Ankle Surgery

NCT05401292 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2074962
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Microbial Colonization; Foot and Ankle Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Microbial Load

  90 days

Study Arms (2)

Iodine or Chlorhexidine Preparation

ACTIVE COMPARATOR

Standard of care with only skin preparation of iodine or chlorhexidine solution prior to sterile draping before surgery.

Drug: Hibiclens

Iodine or Chlorhexidine Scrub Brush Pre-Scrub with Isopropyl Alcohol and Chlorhexidine Soap

ACTIVE COMPARATOR

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; Drug: Isopropyl Alcohol 70% Topical Application Solution

Interventions

Hibiclens DRUG

antiseptic/antimicrobial skin cleanser for skin wound and general skin cleansing

Iodine or Chlorhexidine Preparation; Iodine or Chlorhexidine Scrub Brush Pre-Scrub with Isopropyl Alcohol and Chlorhexidine Soap

Isopropyl Alcohol 70% Topical Application Solution DRUG

First aid antiseptic

Iodine or Chlorhexidine Scrub Brush Pre-Scrub with Isopropyl Alcohol and Chlorhexidine Soap

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

RECRUITING

MeSH Terms

Conditions

Communicable Diseases

Interventions

chlorhexidine gluconate; 2-Propanol

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanols; Alcohols; Organic Chemicals

Central Study Contacts

Vicki L Jones, MEd, CCRP

CONTACT

5738827583; jonesvicki@health.missouri.edu

Kyle Schweser, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Trauma Surgeon, Assistant Professor

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: June 2, 2022
• Study Start: February 15, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)