Skin Preparation for Elective Foot and Ankle Surgery

NCT ID: NCT05401292

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Iodine or Chlorhexidine Preparation

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

Group Type: ACTIVE_COMPARATOR

Hibiclens

Intervention Type: DRUG

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

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).

Group Type: ACTIVE_COMPARATOR

Hibiclens

Intervention Type: DRUG

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

Isopropyl Alcohol 70% Topical Application Solution

Intervention Type: DRUG

First aid antiseptic

Interventions

Hibiclens

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

Intervention Type: DRUG

Isopropyl Alcohol 70% Topical Application Solution

First aid antiseptic

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Kyle Schweser MD

Orthopaedic Trauma Surgeon, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Missouri

Columbia, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vicki L Jones, MEd, CCRP

Role: CONTACT

jonesvicki@health.missouri.edu

5738827583

Kyle Schweser, MD

Role: CONTACT

Facility Contacts

Vicki Jones, MEd, CCRP

Role: primary

jonesvicki@health.missouri.edu

573-882-7583

Other Identifiers

2074962

Identifier Type: -

Identifier Source: org_study_id