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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Skin Burn Degree Second
• Intervention / Treatment: Device: Keramatrix; Device: Mepilex

Detailed Description

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

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77551
      • Shriners Hospitals for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Keramatrix	Device: Keramatrix; Dressing for second degree burn
Active Comparator: Mepilex	Device: Mepilex; Dressing for second degree wound

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: Shriners Hospitals for Children; Keraplast Technologies, LLC
• Investigators: Principal Investigator: Carlos Jimenez, MD, University of Texas

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: November 13, 2012
• First Submitted That Met QC Criteria: February 11, 2013
• First Posted (Estimate): February 13, 2013

Study Record Updates

• Last Update Posted (Estimate): May 14, 2015
• Last Update Submitted That Met QC Criteria: May 12, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Burn; Second-degree
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 12-203