Skin Preparation for Elective Foot and Ankle Surgery

Phase 4

Recruiting

• Conditions: Microbial Colonization; Foot and Ankle Disorders
• Interventions: Drug: Hibiclens; Drug: Isopropyl Alcohol 70% Topical Application Solution

• Registration Number: NCT05401292
• Lead Sponsor: University of Missouri-Columbia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-15
• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-05-27
• Study First Posted: 2022-06-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iodine or Chlorhexidine Scrub Brush Pre-Scrub with Isopropyl Alcohol and Chlorhexidine Soap	Isopropyl Alcohol 70% Topical Application Solution	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).
Iodine or Chlorhexidine Preparation	Hibiclens	Standard of care with only skin preparation of iodine or chlorhexidine solution prior to sterile draping before surgery.
Iodine or Chlorhexidine Scrub Brush Pre-Scrub with Isopropyl Alcohol and Chlorhexidine Soap	Hibiclens	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).

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection	90 days	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

Secondary Outcome Measures

Name	Time	Method
Microbial Load	90 days	effectiveness of reducing microbial load. Comparing original microbial load to final microbial load (CFU/g)

Trial Locations

Locations (1)

University of Missouri; 🇺🇸 Columbia, Missouri, United States