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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Skin Burn Degree Second

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Keramatrix

Group Type ACTIVE_COMPARATOR

Keramatrix

Intervention Type DEVICE

Dressing for second degree burn

Mepilex

Group Type ACTIVE_COMPARATOR

Mepilex

Intervention Type DEVICE

Dressing for second degree wound

Interventions

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Keramatrix

Dressing for second degree burn

Intervention Type DEVICE

Mepilex

Dressing for second degree wound

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No