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

The University of Texas System (UT) logo

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Withdrawn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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Keramatrix
Active Comparator group
Description:
Keramatrix
Treatment:
Device: Keramatrix
Mepilex
Active Comparator group
Description:
Mepilex
Treatment:
Device: Mepilex

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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