drugset / Trial / NCT01668030

Comparison of Wound Bed Establishment in Facial Burns

NCT01668030

Phase 4 Completed 10 enrolled University of Louisville Healthpoint · collab
RandomizedSequentialTriple-blindTreatment

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.

Timeline

Start
2012-02
Primary completion
2013-11
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Bacitracin Unknown Topical
Subject Collagenase Clostridium Histolyticum Protein / enzyme biologic Topical

Indications

No indication recorded.