Chronic Wound
Conditions
Keywords
Chronic wound, Bioactive glass
Brief summary
The goal of this randomized control trial is to test the efficacy and safety of a bioglass wound dressing in patients with chronic wound in different stages. The main question it aims to answer are: * Whether the bioglass wound dressing have better efficacy and safety than blank control in treatment of chronic wound in necrosis stable stage？ * Whether the bioglass wound dressing have better efficacy and safety than blank control in treatment of chronic wound in granulation growth stage？ Participants will be assigned with a 1:1 ratio into intervention group and control group. Participants of intervention group will receive bioglass wound dressing in addition with clinical optimal treatment plan. Participants of control group will only receive clinical optimal treatment plan.
Interventions
DEVICEBioactive glass wound dressing
Bioactive glass wound dressing is a dressing covered on the wound bed
Sponsors
Yunfeng Li
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. The patient is aged 18-80 years old; 2. Ulcerative wounds; 3. In the stage of stable necrosis or granulation growth; 4. Voluntarily participate in this study and sign an informed consent form
Exclusion criteria
1. Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet; 2. Uncontrolled blood glucose, Glucose test#Fasting blood sugar\>15mmol/L, Glycated hemoglobin\>12%; 3. There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented; 4. Serum albumin \< 20 g/L; Hemoglobin\<60 g/L; Platelets\<50 × 10\^9/L; 5. Spreading infection status, currently or about to be treated with antibiotics; 6. Patients with advanced malignant tumors; 7. Active period of autoimmune diseases; 8. Previous allergies to bioactive glass ointment dressings (self originating); 9. The patient is unable to cooperate or has mental disorders; 10. According to the judgment of the researcher, the subject has a clear reason that cannot be removed and affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-week reduction rate of wound area | 2-week |
Secondary
| Measure | Time frame |
|---|---|
| 2-week wound healing rate | 2-week |
Outcome results
None listed