Study of Antibacterial Absorbable Wound Dressing for Treating Chronic Non-Healing Wounds Evaluating Safety and Effectiveness in Adults Aged 18 to 80

What this Trial Is About

Researchers are investigating a new antimicrobial absorbable wound dressing designed to treat chronic non-healing wounds. Previous animal studies showed promising results in wound area reduction and safety, but clinical evidence is lacking. This research integrates modern clinical evaluation methods and chronic wound staging theory to assess the dressings effectiveness and safety in human patients with chronic wounds. The study compares the use of the antimicrobial absorbable wound dressing alongside standard clinical treatment for 3 weeks against standard treatment alone. The dressing is a polyester-based degradable device applied directly to the wound following clinical preparation protocols, including moistening and securing with a secondary dressing to maintain adherence. Participants receive treatment during the 3-week study period. Participants will be assessed for wound area reduction rate at about 3 weeks after starting treatment, which is the primary outcome. Secondary outcomes include the wound healing rate at the same time point. Researchers will monitor safety, wound progression, and any adverse effects throughout the study. The total participation period is at least 3 weeks, during which clinical visits and evaluations will occur to track healing and treatment response.

An Exploratory Research on the Efficacy and Safety of Antibacterial Absorbable Dressing in Chronic Non-healing Wounds