Bioglass Wound Dressing in Treatment of Chronic Wound in Different Stage：a Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Bioglass Wound Dressing in Treatment of Chronic Wound in Different Stage：a Randomized Controlled Trial

Conditions
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Chronic Wound

Intervention / Treatment
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* Device: Bioactive glass wound dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is aged 18-80 years old; Ulcerative wounds; In the stage of stable necrosis or granulation growth; Voluntarily participate in this study and sign an informed consent form Exclusion Criteria: Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet; Uncontrolled blood glucose, Glucose test#Fasting blood sugar>15mmol/L, Glycated hemoglobin>12%; There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented; Serum albumin < 20 g/L; Hemoglobin<60 g/L; Platelets<50 × 10^9/L; Spreading infection status, currently or about to be treated with antibiotics; Patients with advanced malignant tumors; Active period of autoimmune diseases; Previous allergies to bioactive glass ointment dressings (self originating); The patient is unable to cooperate or has mental disorders; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Bioactive glass wound dressing|Bioactive glass wound dressing is a dressing covered on the wound bed|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-week reduction rate of wound area |  | 2-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-week wound healing rate |  | 2-week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic wound, Bioactive glass