Skin Burn Degree Second
Conditions
Keywords
Burn, Second-degree
Brief summary
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
Efficacy in promoting wound healing will be determined through comparison to Mepilex, an established burn wound dressing.
Interventions
DEVICEKeramatrix
Dressing for second degree burn
DEVICEMepilex
Dressing for second degree wound
Sponsors
Keraplast Technologies, LLC
Shriners Hospitals for Children
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing | Duration of hospital stay, an expected average of 0.75 days per every percent burn until wound heals | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection rates | Duration of hospital stay, an expected average of 0.75 days per percent burn until wound heals | Subjects will be monitored for unusual occurences, including signs and symptoms of infection. |
| Scarring | 52 weeks up to 78 weeks | 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. |
| Pain | 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 | Pain will be assessed using pain scales according to age. |
Countries
United States
Outcome results
None listed