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

Study Overview
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Brief Summary
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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.

Detailed Description
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There is currently no gold standard dressing when it comes to treating hand or foot burns, specifically in the pediatric population. Our institution currently utilizes the soft cast technique (SCT) on all of our hand and foot burns. The SCT uses triple antibiotic ointment (TAO) impregnated Adaptic gauze, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban. This dressing is applied one to two times during the first 2 weeks post injury. The underlying dressing is changed to nystatin impregnated Adaptic gauze, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban for the remainder of treatment time or until surgery is indicated for debridement and grafting of wounds. The soft cast technique provides optimal positioning of the wounded hand or foot, allows for a moist wound environment, and offers protection of the injured extremity as the wound heals. The literature reveals that early surgical intervention performed in the first 7 to 10 days post injury has been shown to help achieve maximal function while decreasing the risk of hypertrophic scar formation. A review of the current literature demonstrates silver sulfadiazine (SSD) to be the most frequently used dressing for burn wound treatment in many clinics nationwide. The use of SSD is associated with once to twice daily painful dressing changes and wound exposure that may lead to disruption of newly formed epithelium, wound colonization, subsequent wound infection and deepening of the burn. One major benefit of the SCT is the reduction in required dressing changes, as the soft cast can stay in place for 7-10 days while maintaining optimal hand or foot positioning. This eliminates the need for painful dressing changes. Occasionally in our clinic, we have observed yeast infections under the soft cast when patients require serial casting. Other complications include occasional drying out of the adaptic gauze, which leads to painful dressing removal and interruption of the newly epithelialized wound bed. Mepitel Ag, a new soft silicone dressing produced by Molnlycke Health Care, combines Safetac technology with a silver compound to provide a broad spectrum of antimicrobial coverage, lasting up to 8 days, while minimizing damage to the new epithelium and creating a moist wound environment. The safetac technology protects the wound and the skin. It prevents an outer dressing from sticking to the wound, therefore minimizes trauma and pain. The highly pliable nature and antimicrobial properties of the dressing make it an ideal alternative to TAO and SSD for the treatment of pediatric partial to deep partial thickness hand and foot burns.

Official Title
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A Comparison of Mepitel Ag vs Antibiotic Ointment When Used With the Soft Cast Technique for the Treatment of Pediatric Hand and Foot Burns, a Prospective Study

Conditions
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Burns

Intervention / Treatment
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* Device: triple antibiotic ointment dressing
* Device: Mepitel Ag


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 31 Days
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control- triple antibiotic ointment<br>triple antibiotic ointment (TAO) impregnated Adaptic gauze, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban | Device: triple antibiotic ointment dressing<br>* used for control group under soft cast<br>|
| Experimental: Variable- mepitel Ag<br>mepitel Ag, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban | Device: Mepitel Ag<br>* used for variable/experimental group under soft cast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Wound Appearance From Initial Injury Until Wound Healed | 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. | Up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Pain Level | 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. | Up to 21 days from date of surgery | 
| Presence of Yeast Infection in Burn Wound | 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. | Up to 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric hand burn, pediatric foot burn, mepitel Ag, soft cast technique for burn wound heaing