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

Peking University

Status: Not yet enrolling

Conditions: Chronic Wound

Treatments: Device: Bioactive glass wound dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT05974228

Long2023-CW-Bioglass

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind