Study Stopped
Due to lack of funding from the sponsor this study is being withdrawn.
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2012
CompletedFirst Posted
Study publicly available on registry
February 13, 2013
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMay 14, 2015
May 1, 2015
Same day
November 13, 2012
May 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Infection rates
Duration of hospital stay, an expected average of 0.75 days per percent burn until wound heals
Scarring
52 weeks up to 78 weeks
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
Study Arms (2)
Keramatrix
ACTIVE COMPARATORKeramatrix
Mepilex
ACTIVE COMPARATORMepilex
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Texas Medical Branch, Galvestonlead
- Keraplast Technologies, LLCcollaborator
- Shriners Hospitals for Childrencollaborator
Study Sites (1)
Shriners Hospitals for Children
Galveston, Texas, 77551, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Jimenez, MD
University of Texas
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2012
First Posted
February 13, 2013
Study Start
April 1, 2015
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
May 14, 2015
Record last verified: 2015-05