Wound Heal, Wound Healing Delayed
Conditions
Brief summary
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.
Interventions
DEVICEantimicrobial absorbable wound dressing
Perform wound bed preparation per clinical routine protocols . Choose an appropriately sized product based on wound dimensions. Peel open the outer aluminum foil pouch from the hermetically sealed edge; the inner pouch remains sterile and may be placed in a sterile field . If necessary, rinse surgical gloves with powder-free solution before handling the product. The material can be trimmed in either moist or dry conditions. Sterile room-temperature irrigation solution may be used for moistening as needed Place either side of the product against the wound, ensuring complete coverage with slight overhang beyond the wound edge. Re-moisten the product with sterile room-temperature irrigation solution if required . Use an appropriate secondary dressing to maintain adherence and prevent displacement.
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Months to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Area Reduction Rate at 3 Weeks | Day 21±2 | The 3-week wound area reduction rate (%) is calculated as: Reduction Rate (%) = （Baseline Wound Area (D0)-Wound Area Post-Treatment (D21)）/Baseline Wound Area (D0) × 100% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing Rate at 3 Weeks | Day 21±2 | The percentage of completely healing wound at 3 Weeks |
Countries
China
Outcome results
None listed