Comparing Concomitant Use of ACell MicroMatrix® and ACell Cytal™ to Standard of Care in Stage 3 o… (NCT03283787) | Clinical Trial Compass
CompletedNot Applicable
Comparing Concomitant Use of ACell MicroMatrix® and ACell Cytal™ to Standard of Care in Stage 3 or 4 Pressure Injuries
United States60 participantsStarted 2017-04-01
Plain-language summary
The purpose of this study is to evaluate incidence of complete epithelialization in stage 3 \& 4 pressure ulcers using ACell products.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Provision of signed and dated informed consent form by subject or legally authorized representative.
✓. Stated willingness to comply with all study procedures and availability for the duration of the study.
✓. Male or female patients that are ≥ 21 years of age.
✓. Body Mass Index (BMI) \<45.
✓. At least one Stage 3 or 4 pressure injury (NPUAP Staging Guidelines) present at the Screening and/or Treatment Visit located in any of the following regions:
✓. Occipital
✓. Back
✓. Flank
Exclusion criteria
✕. Surgical treatment of pressure injury 30 days prior to the Treatment Visit and/or pressure injury in previously irradiated areas.
✕. Inability to manage fecal and/or urine incontinence or patient refusal of its maintenance/management (as determined medically necessary). Patient may be rescreened and enrolled if urinary and/or fecal continence status or management change after failure to comply with requirement.
✕. Allergy or hypersensitivity to materials in porcine-based study products (per subject report) or personal preference.
✕. Currently treated for an active malignant disease.