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

Phase 2

Withdrawn

• Conditions: Skin Burn Degree Second
• Interventions: Device: Keramatrix; Device: Mepilex

• Registration Number: NCT01790763
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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 Timeline

• Study First Submitted: 2012-11-13
• Study First Submitted QC: 2013-02-11
• Study First Posted: 2013-02-13
• Study Start: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-12
• Last Update Posted: 2015-05-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Keramatrix	Keramatrix	Keramatrix
Mepilex	Mepilex	Mepilex

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Shriners Hospitals for Children; 🇺🇸 Galveston, Texas, United States