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

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

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.

Inclusion Criteria:

• 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
• Wound Phase : Late necrotic stabilization phase, granulation phase, or epithelial migration phase***
• Consent : Voluntary participation with signed informed consent

Exclusion Criteria:

• 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
• Critical Laboratory Values :

Serum albumin <20 g/L Hemoglobin <60 g/L Platelet count <50×10⁹/L

• Systemic Infection : Disseminated/systemic infection requiring antibiotic therapy
• Malignancy : Advanced cancer patients，Current radiotherapy/chemotherapy，Malignant (cancer-related) ulcers
• Untreated Burns : Full-thickness (third-degree) burns without escharotomy
• Active Autoimmune Disease : Flare-up phase of autoimmune disorders
• Pregnancy/Lactation : Pregnant or breastfeeding women
• Allergy : Hypersensitivity to absorbable wound repair materials or polyhexamethylene biguanide hydrochloride
• Non-compliance : Inability to cooperate or psychiatric disorders
• Investigator's Discretion : Any condition deemed to compromise wound healing or study adherence