N/A N=96 Randomized Treatment

Comparison of Mepitel Ag vs Antibiotic Ointment Used With Soft Cast Technique for Treatment of Pediatric Burns

Burns

Bottom Line

View on ClinicalTrials.gov: NCT02681757 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2019

Primary outcome: Primary: Change in Wound Appearance From Initial Injury Until Wound Healed — 43; 51 Burns

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: triple antibiotic ointment dressing (Device); Mepitel Ag (Device)
Age: Pediatric, Adult · 0+ yrs
Sex: All
Sponsor: University of Colorado, Denver
Primary completion: Sep 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Wound Appearance From Initial Injury Until Wound Healed	43; 51	—
SECONDARY Evaluation of Pain Level	31; 24; 6; 7; 0; 7	—
SECONDARY Presence of Yeast Infection in Burn Wound	5; 6	—

Summary

The aim of this study is to compare Mepitel Ag to Triple antibiotic ointment impregnated Adaptic gauze when used with the soft cast technique to assess overall time to healing, yeast infection rate and parents perception of pain level at time of dressing change on a scale of 1-10. The hypothesis is that Mepitel Ag in combination with the soft cast technique improves wound healing in pediatric partial to deep partial thickness hand and foot burns by decreasing the length of healing time, decreasing the risk of yeast infection, and decreasing pain associated with dressing changes.

Eligibility Criteria

Inclusion Criteria

Children's Hospital Colorado burn patients
Age 31 days to 18 years
Newly diagnosed partial to deep partial or full thickness hand or foot burns, including bilateral or unilateral injury

Exclusion Criteria

silver allergy
silicone allergy
electrical burn
chemical burn
past medical history of immunodeficiency disorders such as diabetes mellitus
h/o AIDs or HIV,
h/o pregnant women
prisoners
decisionally challenged

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02681757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.