Trial Outcomes & Findings for Comparison of Mepitel Ag vs Antibiotic Ointment Used With Soft Cast Technique for Treatment of Pediatric Burns (NCT NCT02681757)

Last Updated: 2019-12-18

Results Overview

Burn will be evaluated every 3-7 days from date of randomization for up to 21 days (End of Study) after application of Mepitel Ag or triple antibiotic ointment impregnated Adaptic gauze to determine if the burn healed or not.

Recruitment status

COMPLETED

Study phase

Target enrollment

96 participants

Primary outcome timeframe

Up to 21 days

Results posted on

2019-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	Control- Triple Antibiotic Ointment triple antibiotic ointment (TAO) impregnated Adaptic gauze, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban triple antibiotic ointment dressing: used for control group under soft cast	Variable- Mepitel Ag mepitel Ag, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban Mepitel Ag: used for variable/experimental group under soft cast
Overall Study STARTED	47	49
Overall Study COMPLETED	47	49
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control- Triple Antibiotic Ointment n=47 Participants triple antibiotic ointment (TAO) impregnated Adaptic gauze, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban triple antibiotic ointment dressing: used for control group under soft cast	Variable- Mepitel Ag n=49 Participants mepitel Ag, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban Mepitel Ag: used for variable/experimental group under soft cast	Total n=96 Participants Total of all reporting groups
Age, Categorical <=18 years	47 Participants n=47 Participants	49 Participants n=49 Participants	96 Participants n=96 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=47 Participants	0 Participants n=49 Participants	0 Participants n=96 Participants
Age, Categorical >=65 years	0 Participants n=47 Participants	0 Participants n=49 Participants	0 Participants n=96 Participants
Age, Continuous	2.3 years n=47 Participants	1.6 years n=49 Participants	1.8 years n=96 Participants
Sex: Female, Male Female	20 Participants n=47 Participants	15 Participants n=49 Participants	35 Participants n=96 Participants
Sex: Female, Male Male	27 Participants n=47 Participants	34 Participants n=49 Participants	61 Participants n=96 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	47 participants n=47 Participants	49 participants n=49 Participants	96 participants n=96 Participants

PRIMARY outcome

Timeframe: Up to 21 days

Population: Some participants had multiple burns. We investigated all burns.

Outcome measures

Outcome measures
Measure	Control- Triple Antibiotic Ointment n=53 Burns triple antibiotic ointment (TAO) impregnated Adaptic gauze, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban triple antibiotic ointment dressing: used for control group under soft cast	Variable- Mepitel Ag n=60 Burns mepitel Ag, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban Mepitel Ag: used for variable/experimental group under soft cast
Change in Wound Appearance From Initial Injury Until Wound Healed	43 Burns	51 Burns

SECONDARY outcome

Timeframe: Up to 21 days from date of surgery

Subject will be evaluated at first post-operative follow up visit ranging from date of surgery up to 21 days (End of Study) for level of pain at time of dressing change based on FLACC scale and calculated per Nurse and parent perceived level of patient pain. "The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2."

Outcome measures

Outcome measures
Measure	Control- Triple Antibiotic Ointment n=47 Participants triple antibiotic ointment (TAO) impregnated Adaptic gauze, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban triple antibiotic ointment dressing: used for control group under soft cast	Variable- Mepitel Ag n=49 Participants mepitel Ag, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban Mepitel Ag: used for variable/experimental group under soft cast
Evaluation of Pain Level 1	6 Participants	7 Participants
Evaluation of Pain Level 3	2 Participants	1 Participants
Evaluation of Pain Level 4	1 Participants	2 Participants
Evaluation of Pain Level 5	2 Participants	0 Participants
Evaluation of Pain Level 6	1 Participants	2 Participants
Evaluation of Pain Level 8	0 Participants	1 Participants
Evaluation of Pain Level 0	31 Participants	24 Participants
Evaluation of Pain Level 2	0 Participants	7 Participants
Evaluation of Pain Level 7	2 Participants	0 Participants
Evaluation of Pain Level Not Reported	2 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 21 days

Population: The unit of observation is a single burn, not an individual patient. This outcome is number of yeast infections per burn dressing group.

Subject will be evaluated every 3-7 days from date of randomization for up to 21 days (End of Study) for clinically observed evidence of yeast infection from visible wound inspection at time of dressing change, i.e.: foul yeast odor, red erythematous rash.

Outcome measures

Outcome measures
Measure	Control- Triple Antibiotic Ointment n=53 Burns triple antibiotic ointment (TAO) impregnated Adaptic gauze, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban triple antibiotic ointment dressing: used for control group under soft cast	Variable- Mepitel Ag n=60 Burns mepitel Ag, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban Mepitel Ag: used for variable/experimental group under soft cast
Presence of Yeast Infection in Burn Wound	5 burns	6 burns

Adverse Events

Control- Triple Antibiotic Ointment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Variable- Mepitel Ag

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Choi Young Mee MD

Children's Hospital Colorado

Phone: 7207770859

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place