Skin Preparation for Elective Foot and Ankle Surgery

Microbial Colonization Clinical Trial

Official title:

Skin Preparation for Elective Foot and Ankle Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05401292
• Other study ID #: 2074962
• Status: Recruiting
• Phase: Phase 4
• Start date: February 15, 2022
• Est. completion date: December 2025

Study information

• Verified date: July 2023
• Source: University of Missouri-Columbia
• Contact: Stacee Baker, MEd, BSN, RN
• Phone: 5738849017
• Email: staceebaker[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Foot and Ankle Disorders
• Infections
• Microbial Colonization

Intervention

Drug:
• Hibiclens
antiseptic/antimicrobial skin cleanser for skin wound and general skin cleansing
• Isopropyl Alcohol 70% Topical Application Solution
First aid antiseptic

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Microbial Load	effectiveness of reducing microbial load. Comparing original microbial load to final microbial load (CFU/g)	90 days