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Clinical Trial NCT07235254 for Chronic Wound, Hard to Heal Wounds, Dressing, Wound he'a'Ling, Wound Healing is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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A RCT of Moist Ag Dressing in Chronic Wound
Clinical Trial NCT07235254 is an interventional study for Chronic Wound, Hard to Heal Wounds, Dressing, Wound he'a'Ling, Wound Healing is not yet recruiting. Enrollment is planned to begin on December 1, 2025 until the trial accrues 40 participants. Led by Peking University Third Hospital, this trial is expected to complete by September 1, 2027. The latest data from ClinicalTrials.gov was last updated on November 19, 2025.
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.
Official Title
Dry Versus Moist Ag Dressings for Local Wound Infections: A Randomized Controlled Trial on Effectiveness and Cost-Effectiveness
Conditions
Chronic WoundHard to Heal WoundsDressingWound He'a'lingWound HealingOther Study IDs
- Long2025-CW-Ag foam dressing
NCT ID Number
Start Date (Actual)
2025-12-01
Last Update Posted
2025-11-19
Completion Date (Estimated)
2027-09-01
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalMOIST Ag dressing Using MepilexAg in conjunction with conventional clinical treatments | Ag Foam Dressing Named Mepilexag Using MepilexAg in conjunction with conventional clinical treatments in chronic local infectious ulcer |
Active ComparatorDry Ag dressing Using dry Ag dressing in conjunction with conventional clinical treatments | DRY Ag Dressing Using dry Ag dressing in conjunction with conventional clinical treatments |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
wound area reduction in two weeks | Pre-treatment area minus post-treatment area, then divided by pre-treatment area | From enrollment to the end of treatment at 2 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
wound healing rate | Percentage of healed wounds to total cases by D14 | From enrollment to the end of treatment at 2 weeks |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- The patient's age ranges from 18 to 80 years old.
- According to the IWII wound infection staging, infected wounds are classified as local infections*.
- The wound type is ulcer, with an ulcer area ranging from 1 to 40 cm².
- The wound stage is in the necrosis stabilization phase, granulation growth phase, or epithelial crawling phase**.
- Voluntary participation in this study and signing the informed consent form
- Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;
- The blood sugar level of diabetes is out of control, with fasting blood sugar > 15 mmol/L and glycosylated hemoglobin ≥ 10%;
- There is active bleeding in the wound, and the conventional basic treatment plan cannot be implemented;
- Serum albumin < 20 g/L; hemoglobin < 60 g/L; platelets < 50 × 109/L;
- Disseminated infection or systemic infection state, and antibiotics are being used or will be used for treatment;
- Patients with advanced malignant tumors;
- The patient is in the active stage of autoimmune diseases;
- The patient has previously been allergic to self-adhesive soft polysilicone silver ion foam dressings (Meipikang Silver) or Anxidean Nano Silver Trauma Patch;
- The patient cannot cooperate or has a mental disorder;
- 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.
Study Responsible Party
Long Zhang, Principal Investigator, Head of Wound Healing Center, Peking University Third Hospital
Study Central Contact
Contact: Long Zhang Executive Deputy Director, Medical Doctor, +86 010-82266699, [email protected]
1 Study Locations in 1 Countries
Beijing Municipality
Peking University Third Hospital, Beijing, Beijing Municipality, 100191, China
Yunfeng Li, Medical Doctor, Contact, +86 010-82267791, [email protected]