NCT01790763WithdrawnPhase 2
Prospective,Randomized, Parallel Study to Compare the Efficacy of Mepilex and Keramatrix in Promoting Healing of Second Degree Burn Wounds
The University of Texas Medical Branch, Galveston2 sites in 1 countryStarted: April 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Locations
- 2
- Primary Endpoint
- Wound Healing
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Day to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Wound Healing
Time Frame: 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 Outcomes
- Scarring(52 weeks up to 78 weeks)
- Infection rates(Duration of hospital stay, an expected average of 0.75 days per percent burn until wound heals)
- 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)
Investigators
Study Sites (2)
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