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

Обзор

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.

Вмешательства

• Устройство antimicrobial 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

Первичные конечные точки

• Wound Area Reduction Rate at 3 Weeks [Срок оценки: Day 21±2]

Вторичные конечные точки (1)

• Wound Healing Rate at 3 Weeks [Срок оценки: Day 21±2]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT07261501 · Long2025-CW-antibiodegrade

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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