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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02904941 |
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Date of registration:
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04/09/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns
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Scientific title:
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Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns: A Randomised Trial |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02904941 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Chile
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Contacts
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Name:
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sandramontedonico@gmail.com Montedonico, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Servicio de Cirugía Pediátrica, Hospital Carlos Van Buren, Valparaíso, Chile |
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Name:
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Sandra Montedonico, M.D. |
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Address:
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Telephone:
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2364246 |
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Email:
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sandramontedonico@gmail.com |
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Affiliation:
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Name:
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Sandra Montedónico, M.D. |
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Address:
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Telephone:
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2364246 |
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Email:
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sandramontedonico@gmail.com |
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Affiliation:
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Name:
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Sebastián San Martín, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Escuela de Medicina, Universidad de Valparaíso, Chile |
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Name:
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Felipe Martínez, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Escuela de Medicina, Universidad de Valparaíso, Chile |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children with an acute burn (<24 hours)
- Burn due to hot liquids.
- Total wound extension at least 5% of total body surface area.
Exclusion Criteria:
- Burns due to fire, chemical burns or hot surfaces.
- Delayed burns (>24 hours).
- Burns extending solely to the head or scalp.
- Burns whose compromise of head or scalp is 50% or more of total burn area.
- Refusal to participate.
Age minimum:
N/A
Age maximum:
15 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Burns
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Intervention(s)
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Procedure: Standard Wound Care
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Device: Synthetic Dressing
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Biological: Amniotic Membrane Dressing
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Primary Outcome(s)
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Total Grafted Skin Area
[Time Frame: Within the first 30 days after randomisation]
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Secondary Outcome(s)
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Length of Hospital Stay
[Time Frame: Within the first 45 days after randomisation.]
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Surgical Debridement
[Time Frame: Within the first 30 days after randomisation]
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Secondary ID(s)
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SA15I20099
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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