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Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures
NCT03385304 · View on ClinicalTrials.gov ↗
Study Summary
The prevention of infection is the single most important goal influencing peri-operative care of patients with open fractures. Standard practice in the management of open fractures includes sterile technique and pre-operative skin preparation with an antiseptic solution. The available solutions kill bacteria and decrease the quantity of native skin flora, thereby decreasing surgical site infection (SSI). While there is extensive guidance on specific procedures for prophylactic antibiotic use and standards for sterile technique, the evidence regarding the choice of antiseptic skin preparation solution is very limited for open fracture surgery.
Conditions Studied
Interventions
- DRUG 10% povidone-iodine (1% free iodine) in purified water
- DRUG 4% chlorhexidine gluconate (CHG) in purified water
Study Locations (15)
Arizona
- The CORE Institute / Banner University Medical Center — Phoenix
- Banner - University Medical Center Tucson — Tucson
Texas
- San Antonio Military Medical Center — Fort Sam Houston
- McGovern Medical School at University of Texas Health Science Center Houston — Houston
Ontario
- Hamilton Health Sciences — Hamilton
- McMaster University, Center for Evidence-Based Orthopaedics — Hamilton
Other
- Hospital Parc Tauli de Sabadell — Barcelona
- Vall d'Hebron University Hospital — Barcelona
California
- University of California San Francisco — San Francisco
Florida
- University of Florida — Gainesville
Indiana
- Indiana University Health Methodist Hospital — Indianapolis
Maryland
- University of Maryland, R Adams Cowley Shock Trauma Center — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,638 participants |
| Start Date | 2018-04-08 |
| Est. Completion | 2022-06-27 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03385304
The ClinicalTrials.gov registry entry for NCT03385304 describes a study currently listed as completed. 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 1,638 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 559 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Surgical Site Infection appearing as the primary indexed condition, and to 2 interventions — of which 10% povidone-iodine (1% free iodine) in purified water 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: NCT03385304 reports 15 study locations spanning 11 distinct geographic areas — top geographies include Arizona, Texas, Ontario. 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 NCT03385304 about?
NCT03385304 is a clinical study titled "Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures". The prevention of infection is the single most important goal influencing peri-operative care of patients with open fractures. Standard practice in the management of open fractures includes sterile technique and pre-operative skin preparation with an antiseptic solution. The available solutions kill...
What is the current status of trial NCT03385304?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,638 participants. The study started on 2018-04-08. Estimated completion is 2022-06-27.
What conditions does trial NCT03385304 study?
This clinical trial studies the following conditions: Surgical Site Infection, Unplanned Fracture-Related Reoperation, Open Appendicular Fracture. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03385304?
The interventions under investigation include: 10% povidone-iodine (1% free iodine) in purified water (DRUG), 4% chlorhexidine gluconate (CHG) in purified water (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03385304?
This trial is sponsored by University of Maryland, Baltimore, which has 559 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03385304 being conducted?
This trial has 15 study locations across Arizona, California, Florida, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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