Comparison of Wound Bed Establishment in Facial Burns

This study is currently recruiting participants.
Verified August 2012 by University of Louisville
Sponsor:
Collaborator:
Healthpoint
Information provided by (Responsible Party):
Carlee Lehna, University of Louisville
ClinicalTrials.gov Identifier:
NCT01668030
First received: August 8, 2012
Last updated: August 16, 2012
Last verified: August 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Difference in wound bed establishment found [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationships between demographic variables, pain, anxiety, itch levels, and wound healing time explored. [ Time Frame: Two years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668030

Contacts
Contact: Carlee Lehna, PhD 502-290-7254 c0lehn01@louisville.edu

Locations
United States, Kentucky
UofL Health Care Recruiting
Louisville, Kentucky, United States, 40202
Contact: Carlee Lehna, PhD       c0lehn01@louisville.edu   
Sponsors and Collaborators
University of Louisville
Healthpoint
Investigators
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 April 23, 2014