NCT05401292 Skin Preparation for Elective Foot and Ankle Surgery
| NCT ID | NCT05401292 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Missouri-Columbia |
| Condition | Microbial Colonization |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-02-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2022-02-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05401292 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Microbial Colonization. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05401292 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05401292 currently recruiting?
Yes, NCT05401292 is actively recruiting participants. Contact the research team at jonesvicki@health.missouri.edu for enrollment information.
Where is the NCT05401292 trial being conducted?
This trial is being conducted at Columbia, United States.
Who is sponsoring the NCT05401292 clinical trial?
NCT05401292 is sponsored by University of Missouri-Columbia. The trial plans to enroll 100 participants.