Comparing Concomitant Use of ACell MicroMatrix® and ACell Cytal™ to Standard of Care in Stage 3 or 4 Pressure Injuries

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) 5 cm from the anus if colostomy not performed.
• For lower extremity ulcers: Adequate arterial blood flow and perfusion near the site of the injury (the foot is warm to the touch and has palpable pulses), per Investigator judgement.
• Confirmed pressure injury versus moisture-associated skin damage or friction injury.
• Ability to maintain an intact occlusive dressing for 4-7 days with reinforcement without contamination of urine or stool.
• Confirmed fecal (Colostomy) and/or urine incontinence (Foley) maintenance/management, if necessary.
• Consent to off-loading (turns) from pressure sites a minimum of every 2 hours (if possible).
• Consent to sharp debridement of necrotic tissue in the wound bed unless the wound has already undergone debridement within 5 days prior to the Treatment Visit.
• For females of reproductive potential (defined as females ≤ 55 years of age): Negative pregnancy test required prior to surgical debridement per hospital procedures.

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.
• Prior diagnosis of active malignant disease, and is less than 1 year disease-free.
• History of malignancy within the wound.
• Presence of any conditions that are contraindicated with NPWT.
• Any condition associated with a wound healing abnormality (e.g.: connective tissue disorder or immune disorder).
• Dermatologic comorbid disease (e.g., cutis laxa or collagen vascular disease).
• Bleeding diathesis.
• Patients with primary treatment ulcers from burns (from exposure to high heat) or venous leg ulcers. A patient may have concomitant non-pressure ulcers present in non-pressure ulcer treatment regions.
• Received biological-based therapy in any pressure wound within 3 months of the Treatment Visit.
• Severe or significant hypoalbuminemia (albumin 12%).
• Subject report of concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
• Subject report of previous participation in other interventional wound healing clinical investigation within 60 days prior to the Screening Visit.
• The subject has any physical or psychiatric condition that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study