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 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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Comparison of Wound Bed Establishment in Facial Burns Using Two Standard Ointments|
- Difference in wound bed establishment found [ Time Frame: Two years ] [ Designated as safety issue: No ]
- Relationships between demographic variables, pain, anxiety, itch levels, and wound healing time explored. [ Time Frame: Two years ] [ Designated as safety issue: No ]
- Whether demographic variables, treatment type, pain, anxiety, and itch levels predict wound healing time. [ Time Frame: Two years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: Single arm study
Double Blind (masked to subject, caregiver, & outcome assessor. Intervention is that either drug is randomized into being applied to either right or left side of face.
Drug: Collagenase versus Bacitracin
Person is their own control. Ointments randomly applied to either side of face.
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|Contact: Carlee Lehna, PhDfirstname.lastname@example.org|
|United States, Kentucky|
|UofL Health Care||Recruiting|
|Louisville, Kentucky, United States, 40202|
|Contact: Carlee Lehna, PhD email@example.com|
|Principal Investigator:||Carlee R. Lehna, PhD, APRN-BC||University of Louisville, School of Nursing|