Comparison of Wound Bed Establishment in Facial Burns

NCT01668030 | Completed Phase 4 Results

• 1 other identifier: 11.0456
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Burns

Keywords

Facial; Partial thickness

Outcome Measures

Primary Outcomes (1)

• Time to Wound Epithelialization

  Time it required the subjects treated with two standard ointments to establish a wound bed.

  Two years

Study Arms (2)

Bacitracin on left, Enzymatic agent on right

EXPERIMENTAL

Subjects were randomized to receive enzymatic agent on right side of face and bacitracin on left.

Drug: Enzymatic agent; Drug: Bacitracin

Bacitractin on right, enzymatic agent on left

EXPERIMENTAL

Subjects were randomized to receive enzymatic agent on left side of face and bacitracin on right.

Drug: Enzymatic agent; Drug: Bacitracin

Interventions

Enzymatic agent DRUG

Enzymatic agent

Bacitracin on left, Enzymatic agent on right; Bacitractin on right, enzymatic agent on left

Bacitracin DRUG

Bacitracin on left, Enzymatic agent on right; Bacitractin on right, enzymatic agent on left

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead
• Healthpoint: collaborator

Study Sites (1)

UofL Health Care

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Burns; Facies

Interventions

Bacitracin

Condition Hierarchy (Ancestors)

Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Small sample size. The study did not differentiate between deep partial thickness and superficial partial thickness burns. another way to trial this study methodology would be to use animal subjects.

Results Point of Contact

• Title: Dr. Carlee Lehna, Associate Professor
• Organization: University of Louisville School of Nursing

carlee.lehna@louisville.edu

502-852-3913

Study Officials

• Carlee R. Lehna, PhD, APRN-BC

  University of Louisville, School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants received both the test drug and the standard of care, one on each side of the face.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: August 17, 2012
• Study Start: February 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: August 1, 2014
• Last Updated: August 28, 2017
• Results First Posted: August 28, 2017

Record last verified: 2017-07

Locations

US (1)