Antimicrobial absorbable wound dressing is a novel polyester-based degradable dressing. Previous preclinical studies have demonstrated promising efficacy, with a 3-week wound area reduction rate of 63.53% in large animal models, outperforming foreign counterparts (49.47%), without significant adverse reactions observed during application. Toxicological risk assessment confirms acceptability, and small animal model studies show no abnormalities in toxicity or sensitization. However, current evidence lacks clinical validation, particularly regarding efficacy and safety in chronic non-healing wounds.
This study integrates modern clinical evaluation methods with chronic wound staging theory to systematically investigate the effectiveness and safety of antimicrobial absorbable wound repair materials in treating chronic non-healing wounds. The research aims to identify optimal indications and provide robust evidence for its clinical efficacy and safety.
Age : 18-80 years
Wound Type : Chronic non-healing ulcers* with no signs of healing progression for ≥1 week
Wound Area : 1-35 cm²
Infection Status : Local infection, contamination, or colonization** as classified by IWII Wound Infection Staging
Severe Comorbidities : Acute myocardial infarction, heart failure, hepatitis, shock, respiratory failure, or other critical conditions requiring stabilization
Uncontrolled Diabetes : Fasting blood glucose >15 mmol/L or HbA1c >12%
Active Wound Hemorrhage : Bleeding precluding standard wound therapy
Systemic Infection : Disseminated/systemic infection requiring antibiotic therapy
Peking University Third Hospital
Lead sponsor