Compare the Efficacy of Mepilex and Keramatrix in Second Degree Burn Wounds

Study Overview
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Brief Summary
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The purpose of this study is to determine the extent to which Keramatrix dressing promotes the healing of second-degree burn wounds in pediatric patients.

Detailed Description
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Efficacy in promoting wound healing will be determined through comparison to Mepilex, an established burn wound dressing.

Official Title
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Prospective,Randomized, Parallel Study to Compare the Efficacy of Mepilex and Keramatrix in Promoting Healing of Second Degree Burn Wounds

Conditions
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Skin Burn Degree Second

Intervention / Treatment
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* Device: Keramatrix
* Device: Mepilex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient age 0-18 years old Flame or scald burn 10-30% total body surface area burned Partial-thickness second-degree burns Admission within 72 hours of burn injury Clean non-infected wound as diagnosed by the attending physician Exclusion Criteria: Patient older than 18 Causes other than flame or scald injuries (ie.chemical or frostbite) Wounds noted to be contaminated or infected Patients who have received previous treatment efforts (topical dressings or previous wound debridement) Pregnancy lactation Co-morbidity which may compromise healing: known history of AIDS, ARC, HIV, cancer, autoimmune diseases,cirrhosis, tuberculosis, chronic glucocorticoid therapy, diabetes mellitus, renal insufficiency, hepatic disease, congestive heart failure prior to burn injury, associated severe head injury requiring specific treatment known allergy to sheep's wool

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Keramatrix<br>Keramatrix | Device: Keramatrix<br>* Dressing for second degree burn<br>|
| Active Comparator: Mepilex<br>Mepilex | Device: Mepilex<br>* Dressing for second degree wound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Healing | Wound healing will be determined by measuring wound surface area. Wound surface area will be determined through planimetry, which will be performed on digital photographs of the wounds. | Duration of hospital stay, an expected average of 0.75 days per every percent burn until wound heals | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection rates | Subjects will be monitored for unusual occurences, including signs and symptoms of infection. | Duration of hospital stay, an expected average of 0.75 days per percent burn until wound heals | 
| Scarring | Scarring will be evaluated using the Vancouver Clinical Scar Scale. Assessments of graft pigmentation, vascularity, pliability and height will be performed at follow-up visits. | 52 weeks up to 78 weeks | 
| Pain | Pain will be assessed using pain scales according to age. | duration of hospital stay, an expected average of 0.75 days per every percent burn until wound heals, up to 3 times a week during dressing changes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burn, Second-degree