Phase 4 Study Comparing Altrazeal Transforming Powder Dressing to Standard Care for Stage 2, 3, and 4 Pressure Injuries Randomized, Open-Label, Multi-Center Trial Over 12 Weeks

What this Trial Is About

Pressure injuries, also known as pressure ulcers, affect over 2.5 million people in the United States and range from intact skin to severe wounds with deep tissue loss. This study focuses on patients with stage 2, 3, and 4 pressure injuries and aims to compare the standard care treatment recommended by the National Pressure Injury Advisory Panel to a new treatment using Altrazealae Transforming Powder Dressing, a wound hydrogel device. The study evaluates whether dressing changes can be reduced and compares wound healing, complications, pain, quality of life, and costs between the two treatments. Participants will be randomly assigned to one of two groups one receiving standard wound dressings such as hydrocolloid, hydrogel, foam, or negative pressure therapy, and the other receiving the Altrazealae Transforming Powder Dressing, which conforms to the wound and protects it from bacteria. Altrazealae can remain on the wound for up to 30 days and is topped off as needed during visits. Both groups receive treatments over 12 consecutive weeks, with the option to end earlier if the wound heals. During the study, participants will attend up to 12 visits over 12 weeks for wound evaluations including cleaning, photographs, and measurements. They will also complete pain assessments, quality of life surveys, and questionnaires about wound care and offloading device use. Researchers will monitor dressing changes, healing progress, complications, pain, and quality of life. At study end, participants will complete a satisfaction survey about the wound dressing experience.

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