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Comparison of Wound Bed Establishment in Facial Burns
NCT01668030 · View on ClinicalTrials.gov ↗
Study Summary
Forty percent of patients admitted to the contributing regional burn unit over a five month period received facial burns (n=14). The purpose of this study is to examine if the time until a granulation bed is well established can be decreased be using an enzymatic agent, when compared to a second standard ointment, for patients with partial-thickness facial burns. The current study will use a prospective, experimental study design in which each individual will be their own matched control. That is, each individual will receive both the experimental ointment (one-side of the face) and the standard ointment (other-side of the face). Outcomes measured will be the benefits (e.g., decreased in the time until granulation bed establishment) one ointment achieves in partial-thickness facial burns when compared to a second ointment. Exploratory analyses will examine the relationships among demographic variables, granulation bed establishment time, pain, anxiety, itching, and scarring. That is, testing whether the time until granulation establishment may be associated with an individual's demographic variables, treatment type, pain, anxiety, itching levels, and scarring. Significance for all analysis will be at the 0.05 level. The investigators hypothesize that promoting rapid granulation bed establishment will decrease hospital length of stays, costs, risk of infection, and possibly associated appearance changes. The results from the current study will provide preliminary findings for a future, more sophisticated study.
Conditions Studied
Interventions
- DRUG Enzymatic agent
- DRUG Bacitracin
Study Locations (1)
Kentucky
- UofL Health Care — Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01668030
The ClinicalTrials.gov registry entry for NCT01668030 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 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Louisville, which has 260 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Burns appearing as the primary indexed condition, and to 2 interventions — of which Enzymatic agent 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: NCT01668030 reports 1 study location spanning 1 distinct geographic area — top geographies include Kentucky. 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 NCT01668030 about?
NCT01668030 is a clinical study titled "Comparison of Wound Bed Establishment in Facial Burns". Forty percent of patients admitted to the contributing regional burn unit over a five month period received facial burns (n=14). The purpose of this study is to examine if the time until a granulation bed is well established can be decreased be using an enzymatic agent, when compared to a second sta...
What is the current status of trial NCT01668030?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2012-02. Estimated completion is 2014-08.
What conditions does trial NCT01668030 study?
This clinical trial studies the following conditions: Burns. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01668030?
The interventions under investigation include: Enzymatic agent (DRUG), Bacitracin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01668030?
This trial is sponsored by University of Louisville, which has 260 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01668030 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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