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

The University of Texas System (UT)

Status and phase

Withdrawn

Phase 3

Phase 2

Conditions

Skin Burn Degree Second

Treatments

Device: Mepilex

Device: Keramatrix

Study type

Interventional

Funder types

Other

Identifiers

NCT01790763

12-203

Details and patient eligibility

About

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.

Full description

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

Sex

All

Ages

1 day to 18 years old

Volunteers

No Healthy Volunteers

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