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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 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.

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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.

Conditions Studied

Interventions

  • DRUG Enzymatic agent
  • DRUG Bacitracin

Study Locations (1)

Kentucky

  • UofL Health Care - Louisville

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2012-02
Est. Completion 2014-08
Phase Phase 4

Sponsor

University of Louisville

217 total trials

What the Registry Record Tells You About NCT01668030

The ClinicalTrials.gov registry entry for NCT01668030 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 83-participant average among 36 other Burns trials with a reported enrollment target (88% lower). The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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

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