Chronic Wound, Dressing, Hard to Heal Wounds, Wound he'a'Ling, Wound Healing
Conditions
Brief summary
This study aims to explore the differences in efficacy and cost-effectiveness between self-adhesive soft polysilicone silver ion foam dressings and traditional silver dressings in local infected wounds through a prospective randomized controlled study. The goal is to provide evidence-based medical support for clinical application, further shorten the wound healing time, and reduce the economic burden on the medical system and patients.
Interventions
DEVICEAg foam dressing named MepilexAg
Using MepilexAg in conjunction with conventional clinical treatments in chronic local infectious ulcer
DEVICEDry Ag dressing
Using dry Ag dressing in conjunction with conventional clinical treatments
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. The patient's age ranges from 18 to 80 years old. 2. According to the IWII wound infection staging, infected wounds are classified as local infections\*. 3. The wound type is ulcer, with an ulcer area ranging from 1 to 40 cm². 4. The wound stage is in the necrosis stabilization phase, granulation growth phase, or epithelial crawling phase\*\*. 5. Voluntary participation in this study and signing the 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. The blood sugar level of diabetes is out of control, with fasting blood sugar \> 15 mmol/L and glycosylated hemoglobin ≥ 10%; 3. There is active bleeding in the wound, and the conventional basic treatment plan cannot be implemented; 4. Serum albumin \< 20 g/L; hemoglobin \< 60 g/L; platelets \< 50 × 109/L; 5. Disseminated infection or systemic infection state, and antibiotics are being used or will be used for treatment; 6. Patients with advanced malignant tumors; 7. The patient is in the active stage of autoimmune diseases; 8. The patient has previously been allergic to self-adhesive soft polysilicone silver ion foam dressings (Meipikang Silver) or Anxidean Nano Silver Trauma Patch; 9. The patient cannot cooperate or has a mental disorder; 10. According to the investigator's judgment, the subject has clear reasons that affect wound healing and is not suitable for this study or cannot comply with the requirements of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| wound area reduction in two weeks | From enrollment to the end of treatment at 2 weeks | Pre-treatment area minus post-treatment area, then divided by pre-treatment area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| wound healing rate | From enrollment to the end of treatment at 2 weeks | Percentage of healed wounds to total cases by D14 |
Countries
China
Contacts
Primary ContactLong Zhang Executive Deputy Director, Medical Doctor
Outcome results
None listed