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RECRUITING Phase 4

Skin Preparation for Elective Foot and Ankle Surgery

NCT05401292 · View on ClinicalTrials.gov ↗

Study 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

  • DRUG Hibiclens
  • DRUG Isopropyl Alcohol 70% Topical Application Solution

Study Locations (1)

Missouri

  • University of Missouri — Columbia

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2022-02-15
Est. Completion 2025-12
Phase Phase 4

Sponsor

University of Missouri-Columbia

275 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05401292

The ClinicalTrials.gov registry entry for NCT05401292 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Missouri-Columbia, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Microbial Colonization appearing as the primary indexed condition, and to 2 interventions — of which Hibiclens is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05401292 reports 1 study location spanning 1 distinct geographic area — top geographies include Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05401292 about?

NCT05401292 is a clinical study titled "Skin Preparation for Elective Foot and Ankle Surgery". 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 a...

What is the current status of trial NCT05401292?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2022-02-15. Estimated completion is 2025-12.

What conditions does trial NCT05401292 study?

This clinical trial studies the following conditions: Microbial Colonization, Foot and Ankle Disorders. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05401292?

The interventions under investigation include: Hibiclens (DRUG), Isopropyl Alcohol 70% Topical Application Solution (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05401292?

This trial is sponsored by University of Missouri-Columbia, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05401292 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial