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Phase 4 N=20 Randomized Triple-blind Treatment

Comparison of Wound Bed Establishment in Facial Burns

Burns

Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Time to Wound Epithelialization — 37.4; 37.6 days — p=.0853

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Enzymatic agent (Drug); Bacitracin (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Louisville
Primary completion
Nov 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Time to Wound Epithelialization
37.4; 37.6 .0853

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.

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01668030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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