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
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new antimicrobial absorbable wound dressing designed to treat chronic non-healing wounds. Previous animal studies showed promising results in wound area reduction and safety, but clinical evidence is lacking. This research integrates modern clinical evaluation methods and chronic wound staging theory to assess the dressing's effectiveness and safety in human patients with chronic wounds. The study compares the use of the antimicrobial absorbable wound dressing alongside standard clinical treatment for 3 weeks against standard treatment alone. The dressing is a polyester-based degradable device applied directly to the wound following clinical preparation protocols, including moistening and securing with a secondary dressing to maintain adherence. Participants receive treatment during the 3-week study period. Participants will be assessed for wound area reduction rate at about 3 weeks after starting treatment, which is the primary outcome. Secondary outcomes include the wound healing rate at the same time point. Researchers will monitor safety, wound progression, and any adverse effects throughout the study. The total participation period is at least 3 weeks, during which clinical visits and evaluations will occur to track healing and treatment response.
CONDITIONS
Brief 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 signs of healing progression for at least 1 week
- Wound area between 1 and 35 square centimeters
- Local infection, contamination, or colonization as classified by IWII Wound Infection Staging
- Wound in late necrotic stabilization phase, granulation phase, or epithelial migration phase
- Voluntary participation with signed informed consent
You will not qualify if you...
- Severe comorbidities such as acute myocardial infarction, heart failure, hepatitis, shock, respiratory failure, or other critical conditions
- Uncontrolled diabetes with fasting blood glucose over 15 mmol/L or HbA1c over 12%
- Active wound hemorrhage preventing standard wound therapy
- Critical laboratory values: serum albumin below 20 g/L, hemoglobin below 60 g/L, or platelet count below 50x10^9/L
- Disseminated or systemic infection requiring antibiotic therapy
- Advanced cancer, current radiotherapy/chemotherapy, or malignant ulcers
- Untreated full-thickness (third-degree) burns without escharotomy
- Active flare-up phase of autoimmune diseases
- Pregnancy or breastfeeding
- Allergy to absorbable wound repair materials or polyhexamethylene biguanide hydrochloride
- Inability to cooperate or psychiatric disorders
- Any condition that may compromise 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive standard clinical treatment for chronic non-healing wounds. Those in the test group also use an antimicrobial absorbable wound dressing for 3 weeks to promote wound healing.
Weekly visits for up to 3 weeks
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
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