RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tiss… (NCT04091672) | Clinical Trial Compass
CompletedNot Applicable
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
United States65 participantsStarted 2020-03-02
Plain-language summary
A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.
Who can participate
Age range5 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The patient requires autografting for treatment of an acute full-thickness skin defect (e.g., trauma- or surgery-related).
✓. The maximum area requiring autografting is 50% Total Body Surface Area (TBSA).
✓. Two comparable areas requiring autografting, each at least 160 cm2 (or 320 cm2 contiguous), excluding face and genitalia. When hands or joints are included in the treatment areas, comparability of treatment areas means that each area (RECELL and Control) must include the same contralateral joint and/or hand.
✓. The patient is at least 5 years of age.
✓. The patient (or parent/guardian) is willing and able to comply with all compulsory study procedures and visit schedule.
✓. The patient agrees to abstain from any other treatment (e.g., external fixation) of the study treatment areas for the duration of his/her participation the study (1 year).
✓. The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation the study (1 year).
✓. In the opinion of the investigator, the patient and/or guardian must be able to:
Exclusion criteria
✕. Not able to understand English or Spanish.
✕. The area requiring autografting sustained a burn injury.
✕. The treatment area has previously failed to heal subsequent to surgical intervention for closure.