Comparison of Wound Bed Establishment in Facial Burns
Completed · Phase 4
Conditions studied: Burns
In brief
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.
Key facts
- Study ID
- NCT01668030
- Run by
- University of Louisville
- People needed
- 10
- Starts
- 2012-02-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2017-08-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- patients (over the age of 18 years) admitted to the burn unit with a minimum of 1% partial-thickness burns each side of the face.
You may not qualify if…
- patients with superficial or full-thickness facial burns;
- patients receiving facial grafts; patients with burns from chemical or contact sources;
- patients with wound infection;
- any patients starting treatment 24 hours after burn injury;
- patients with known sensitivity to either standard treatment; and
- any women by history who are pregnant or breast feeding.
Where it is running
- UofL Health Care — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
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