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About
A prospective, parallel-arm, randomized (1:1) multicenter trial to demonstrate that RECELL treatment of partial-thickness burn injuries, can safely and effectively increase the incidence of Day 10 healing compared with a standardized wound dressing.
Enrollment
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Inclusion criteria
Male or female patients aged 1 through 16 years (inclusive) with a partial-thickness thermal burn injury.
The patient has a thermal burn injury that is:
The Index Burn must be a clean partial-thickness burn injury > or = to 160 cm2 and between 2-20% BSA (inclusive).
The Index Burn may not cover the face, hand, foot or perineum/genitalia (Note: a patient with wounds in these areas may be enrolled but the Index Burn Area may not include these areas).
The patient and/or guardian agrees to comply with all compulsory study procedures and visit schedule.
The patient and/or parent/guardian agrees to abstain from any other treatment for closure of the Index Burn for the duration of the study, unless medically necessary.
The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
In the opinion of the investigator, the patient and/or parent/guardian must be able to:
Exclusion criteria
Post-Randomization Inclusion Criteria (prior to treatment):
Post-Randomization Exclusion Criteria (prior to treatment):
Consented subjects who do not meet the post-randomization eligibility criteria and did not receive study treatment will be followed through the Day 28 visit and then withdrawn from the study. The criteria for which exclusion was based will be documented.
Primary purpose
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Interventional model
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19 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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