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NCT05401292 · ClinicalTrials.gov registry record · Phase 4
Skin Preparation for Elective Foot and Ankle Surgery
A Phase 4 study of Microbial Colonization and Foot and Ankle Disorders, sponsored by University of Missouri-Columbia.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05401292: Recruiting Phase 4 study of Microbial Colonization and Foot and Ankle Disorders, sponsored by University of Missouri-Columbia.
NCT05401292 is a Phase 4 study of Microbial Colonization and Foot and Ankle Disorders that is actively recruiting participants, run by University of Missouri-Columbia. The registered enrollment target is 100 participants, below the 12,650-participant average among 20 other Microbial Colonization trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05401292, a Phase 4 study of Microbial Colonization and Foot and Ankle Disorders, is actively recruiting participants, sponsored by University of Missouri-Columbia.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Hibiclens
- DRUG Isopropyl Alcohol 70% Topical Application Solution
Study Locations (1)
Missouri
- University of Missouri - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-02-15 |
| Est. Completion | 2025-12 |
| Phase | Phase 4 |
What NCT05401292 shows while recruiting
NCT05401292 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 12,650-participant average among 20 other Microbial Colonization trials with a reported enrollment target (99% lower).
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.
NCT05401292 reports a single indexed study location in Missouri.
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.
What interventions are being tested in trial NCT05401292?
The interventions under investigation include: Hibiclens (DRUG), Isopropyl Alcohol 70% Topical Application Solution (DRUG).
Who is sponsoring clinical trial NCT05401292?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Microbial Colonization
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05401292's enrollment target sits among peer trials
100 12th of 20 higher than 9 of 20 other Microbial Colonization trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Microbial Colonization trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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