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Comparison of Wound Bed Establishment in Facial Burns

This study has been completed.
Sponsor:
Collaborator:
Healthpoint
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT01668030
First received: August 8, 2012
Last updated: July 27, 2017
Last verified: July 2017
  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: Enzymatic agent Drug: Bacitracin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
Participants received both the test drug and the standard of care, one on each side of the face.
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:
  • Time to Wound Epithelialization [ Time Frame: Two years ]
    Time it required the subjects treated with two standard ointments to establish a wound bed.


Enrollment: 10
Actual Study Start Date: February 2012
Study Completion Date: August 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bacitracin on left, Enzymatic agent on right
Subjects were randomized to receive enzymatic agent on right side of face and bacitracin on left.
Drug: Enzymatic agent
Enzymatic agent
Drug: Bacitracin
Experimental: Bacitractin on right, enzymatic agent on left
Subjects were randomized to receive enzymatic agent on left side of face and bacitracin on right.
Drug: Enzymatic agent
Enzymatic agent
Drug: Bacitracin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668030

Locations
United States, Kentucky
UofL Health Care
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Healthpoint
Investigators
Principal Investigator: Carlee R. Lehna, PhD, APRN-BC University of Louisville, School of Nursing
  More Information

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT01668030     History of Changes
Other Study ID Numbers: 11.0456
Study First Received: August 8, 2012
Results First Received: April 5, 2017
Last Updated: July 27, 2017

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
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on September 19, 2017