RES® Prepared With RECELL® Compared to Standard of Care Dressings of Partial-thickness Burns in A… (NCT03626701) | Clinical Trial Compass
TerminatedNot Applicable
RES® Prepared With RECELL® Compared to Standard of Care Dressings of Partial-thickness Burns in Ages 1-16 Years
Stopped: In June 2021, the US FDA approved expanded use of the RECELL System for treatment of acute full-thickness thermal burns in patients 1-month of age and older (removing the prior limitation of use in patients younger than 18 years of age).
United States19 participantsStarted 2020-03-03
Plain-language summary
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.
Who can participate
Age range1 Year – 16 Years
SexALL
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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:
✓. ≤ 30% TBSA (exclusive of superficial areas) and
✓. ≤ 10% of the burn injury TBSA is a full-thickness burn.
✓. 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.
Exclusion criteria
✕. Not able to understand English or Spanish.
✕. Burns caused by chemicals, electricity or radiation.
✕. Patients presenting with only 3rd-degree/full-thickness wounds which require immediate autografting.
✕. Burn injury has had prior treatment for definitive closure.
✕. Patients for whom use of sedation/general anesthesia is not medically appropriate.
✕. Superficial/trivial burns or burns that in the investigator's opinion appear to be healing sufficiently such that care under this protocol would be inappropriate.
✕. Patient requires immediate or staged surgical procedures for closure of their partial-thickness burns.
✕. Conditions, e.g., previous burn injury to study area, poor nutritional status, poorly controlled diabetes mellitus (HbA1c \>9%), that in the investigator's opinion may compromise subject safety or trial objectives.