Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries

Inclusion Criteria

• 18 to 85 years of age;
• Stage 2, 3, or 4 Pressure Injuries;
• Wound exudate is mild to moderate;
• No clinically active wound infection (clinical diagnosis);
• Able and willing to provide written (not proxy) informed consent;
• Clinically stable, as determined by assessment of medical history, vital signs, physical examination, and laboratory testing prior to enrollment.

Exclusion Criteria

• Known allergy or hypersensitivity to TPD or its components;
• Pressure injuries classified as unstageable, deep tissue pressure injury, or Stage 1;
• Heavily exudative wounds;
• Wound infection as defined as the presence of a least two of the following: local swelling or in duration, erythema >0.5cm around the ulcer in any direction, local tenderness or pain local warmth and purulent discharge;
• Poorly controlled diabetes with HgbA1C >12 (as documented in the last 3 months);
• Body Mass Index (BMI) >45 kg/m2;
• Venous stasis disease or lymphedema in the affected limb (if wound is located on the limb);
• Moderate to severe chronic limb ischemia Ankle Brachial Index (ABI) \<0.7 on the affected limb, if wound is located on the limb);
• Received immunosuppression or biologics in the last six weeks and/or is expected to receive either at any point during the study;
• Selected concurrent treatments (e.g., hyperbaric oxygen, topical oxygen therapy, electrical stimulation, ultrasound, cellular or acellular skin substitutes) during study period that may impact study outcomes;
• Wounds with necrosis unable to undergo prior definitive debridement;
• Fistulas;
• Active gangrene;
• Untreated HIV;
• Currently pregnant or lactating;
• Impending organ transplant;
• Vulnerable populations including prisoners, pediatrics, cognitively impaired, unconscious, and illiterate patients;
• Unwilling or unable to comply with offloading recommendations;
• If, in the opinion of the clinical investigator, a subject is a poor candidate for this study because:

• Unable to keep research appointments;
• Poorly controlled incontinence which may impact study outcomes (e.g., depending on the location of the wound);
• Participated in another investigative study within 3 months of enrollment that could interfere with study outcomes;
• Active alcohol or substance abuse (cocaine, heroin, or other substances) that may interfere with healing or subject compliance with visit schedules;
• Concurrent clinical condition(s) that could pose a health risk to patient or influence outcome of study;
• Not suitable for study participation. -