Skin Preparation for Elective Foot and Ankle Surgery

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05401292

Enrollment

100

Registered

2022-06-02

Start date

2022-02-15

Completion date

2026-12-01

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot and Ankle Disorders, Microbial Colonization

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.

Interventions

DRUGHibiclens

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

DRUGIsopropyl Alcohol 70% Topical Application Solution

First aid antiseptic

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Contacts

CONTACTVicki L Jones, MEd, CCRP

jonesvicki@health.missouri.edu5738827583

CONTACTKyle Schweser, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026