Improving skin preparation for foot and ankle surgery
Skin Preparation for Elective Foot and Ankle Surgery
PHASE4 · University of Missouri-Columbia · NCT05401292
This study tests if a new skin cleaning method before foot and ankle surgery can help lower the risk of infections compared to the usual cleaning method.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Missouri-Columbia (other) |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT05401292 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of an enhanced skin cleaning protocol using isopropyl alcohol and chlorhexidine soap prior to standard skin preparation for elective foot and ankle surgeries. The goal is to reduce microbial load and the incidence of surgical site infections (SSIs), which are a significant concern in surgical procedures. Participants will be divided into two groups: one receiving the enhanced pre-scrub and the other receiving the standard care. The study aims to determine if the additional pre-scrub can significantly lower the SSI rates compared to the current standard practices.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are scheduled for elective foot and ankle surgeries.
Not a fit: Patients with trauma-related surgeries, open injuries, or those undergoing non-elective procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of surgical site infections for patients undergoing elective foot and ankle surgeries.
How similar studies have performed: While the approach of enhancing skin preparation is common, the specific combination of isopropyl alcohol and chlorhexidine soap in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Columbia, Missouri
- University of Missouri — Columbia, Missouri, United States (RECRUITING)
Study contacts
- Study coordinator: Vicki L Jones, MEd, CCRP
- Email: jonesvicki@health.missouri.edu
- Phone: 5738827583
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Microbial Colonization, Foot and Ankle Disorders