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NCT01668030 · ClinicalTrials.gov registry record · Phase 4
Comparison of Wound Bed Establishment in Facial Burns
A Phase 4 study of Burns, sponsored by University of Louisville.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT01668030: Completed Phase 4 study of Burns, sponsored by University of Louisville.
NCT01668030 is a Phase 4 study of Burns that has completed, run by University of Louisville. The registered enrollment target is 10 participants, below the 83-participant average among 36 other Burns trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01668030, a Phase 4 study of Burns, has completed, sponsored by University of Louisville.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Time it required the subjects treated with two standard ointments to establish a wound bed.
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 |
What the finished NCT01668030 record still lists
NCT01668030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 83-participant average among 36 other Burns trials with a reported enrollment target (88% lower).
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.
NCT01668030 reports a single indexed study location in Kentucky.
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.
What interventions are being tested in trial NCT01668030?
The interventions under investigation include: Enzymatic agent (DRUG), Bacitracin (DRUG).
Who is sponsoring clinical trial NCT01668030?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Burns
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 NCT01668030's enrollment target sits among peer trials
10 32nd of 36 higher than 4 of 36 other Burns trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Burns 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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