Short-Term Safety and Performance of Two Wound Dressings Evaluation

Chronic wounds, including venous leg ulcers, diabetic foot ulcers, and pressure ulcers, are defined as wounds that fail to heal within 4-8 weeks despite appropriate care. They represent a significant health burden due to prolonged healing, risk of infection, recurrence, and impact on quality of life and healthcare costs. Their development is multifactorial and often linked to vascular impairments, which reduce oxygen and nutrient supply. This leads to impaired tissue repair, persistent inflammation, and increased susceptibility to infection.

Standard treatment includes wound debridement, infection control, maintaining a moist environment, and managing pain and exudate. POLTX\_Fiber is an absorbent gelling fiber dressing designed to improve moisture balance, manage exudate, and reduce bacterial load, with established safety and CE marking.

A post-market clinical follow-up study will compare POLTX\_Fiber with Suprasorb® Liquacel Pro over a 30-day period in an outpatient setting. The study evaluates wound healing, infection status, usability, pain, and patient satisfaction. It is conducted in accordance with EU and Swiss regulations, ensures qualified investigators, and considers sex and gender differences in the analysis.