Trial Outcomes & Findings for Comparison of Wound Bed Establishment in Facial Burns (NCT NCT01668030)

Last Updated: 2017-08-28

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

Two years

Results posted on

2017-08-28

Patients were recruited from hospital burn unit.

Unit of analysis: Cheek (side of face)

Participant milestones
Measure	Bacitracin Treated Side of Face Bacitractin was applied to one side of face.	Enzymatic Agent Treatment Side of Face Enzymatic agent applied to cheek
Overall Study STARTED	10 10	10 10
Overall Study COMPLETED	10 10	10 10
Overall Study NOT COMPLETED	0 0	0 0

Withdrawal data not reported

Comparison of Wound Bed Establishment in Facial Burns

Baseline characteristics by cohort
Measure	All Study Participants n=10 Participants 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. Enzymatic treatment versus Bacitracin: Person is their own control. Ointments randomly applied to either side of face.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

Timeframe: Two years

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

Outcome measures
Measure	Bacitracin Treated Side of Face n=10 cheeks (side of face) 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. Enzymatic agent versus Bacitracin: Person is their own control. Ointments randomly applied to either side of face.	Enzymatic Agent Treatment Side of Face n=10 cheeks (side of face) 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. Enzymatic agent versus Bacitracin: Person is their own control. Ointments randomly applied to either side of face.
Time to Wound Epithelialization	37.4 days	37.6 days

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Adverse event data not reported

Adverse event data not reported

University of Louisville School of Nursing

Phone: 502-852-3913