Comparison of Wound Bed Establishment in Facial Burns
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Burns |
Drug: Collagenase versus Bacitracin |
Phase 4 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 30 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Carlee Lehna, PhD | 502-290-7254 | c0lehn01@louisville.edu |
| United States, Kentucky | |
| UofL Health Care | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Carlee Lehna, PhD c0lehn01@louisville.edu | |
| Principal Investigator: | Carlee R. Lehna, PhD, APRN-BC | University of Louisville, School of Nursing |
More Information
No publications provided
| Responsible Party: | Carlee Lehna, Associate Professor, University of Louisville |
| ClinicalTrials.gov Identifier: | NCT01668030 History of Changes |
| Other Study ID Numbers: | 11.0456 |
| Study First Received: | August 8, 2012 |
| Last Updated: | August 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Louisville:
|
Facial Partial thickness |
Additional relevant MeSH terms:
|
Burns Wounds and Injuries Bacitracin Anti-Infective Agents, Local |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 19, 2013