An Exploratory Research on the Efficacy and Safety of Antibacterial Absorbable Dressing in Chronic Non-healing Wounds
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Wound Area Reduction Rate at 3 Weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
control group
standard clinical treatment
test group
On the basis of standard clinical treatment, use of antimicrobial absorbable wound dressing for 3 weeks
干预措施: antimicrobial absorbable wound dressing (Device)
结局指标
主要结局
Wound Area Reduction Rate at 3 Weeks
时间窗: 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%
次要结局
- Wound Healing Rate at 3 Weeks(Day 21±2)
研究者
Long Zhang
Professor, Head of Wound Healing Center
Peking University Third Hospital