Actively Recruiting
An Exploratory Research on the Efficacy and Safety of Antibacterial Absorbable Dressing in Chronic Non-healing Wounds
Led by Peking University Third Hospital · Updated on 2025-12-03
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Exploratory Research on the Efficacy and Safety of Antibacterial Absorbable Dressing in Chronic Non-healing Wounds
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Chronic non-healing ulcers with no healing progression for at least 1 week
- Wound area between 1 and 35 cm²
- Local infection, contamination, or colonization as classified by IWII Wound Infection Staging
- Wound in late necrotic stabilization, granulation, or epithelial migration phase
- Voluntary participation with signed informed consent
You will not qualify if you...
- Severe comorbid conditions such as acute myocardial infarction, heart failure, hepatitis, shock, or respiratory failure requiring stabilization
- Uncontrolled diabetes with fasting blood glucose >15 mmol/L or HbA1c >12%
- Active wound bleeding that prevents standard wound therapy
- Very low serum albumin (<20 g/L), hemoglobin (<60 g/L), or platelet count (<50×10⁹/L)
- Systemic infection requiring antibiotic treatment
- Advanced cancer, current radiotherapy or chemotherapy, or malignant ulcers
- Untreated full-thickness burns without escharotomy
- Active flare-up of autoimmune diseases
- Pregnant or breastfeeding women
- Allergy to absorbable wound materials or polyhexamethylene biguanide hydrochloride
- Inability to cooperate or having psychiatric disorders
- Any condition that could affect wound healing or study adherence as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here