A RCT of Moist Ag Dressing in Chronic Wound

Dry Versus Moist Ag Dressings for Local Wound Infections: A Randomized Controlled Trial on Effectiveness and Cost-Effectiveness

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Wound; Wound Healing; Hard to Heal Wounds; Dressing; Wound he'a'Ling
• Intervention / Treatment: Device: Ag foam dressing named MepilexAg; Device: Dry Ag dressing

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Long Zhang Executive Deputy Director, Medical Doctor; Phone Number: +86 010-82266699; Email: longzh2000@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Peking University Third Hospital
      • Contact: Yunfeng Li, Medical Doctor; Phone Number: +86 010-82267791; Email: liyunfeng1106@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MOIST Ag dressing; Using MepilexAg in conjunction with conventional clinical treatments	Device: Ag foam dressing named MepilexAg; Using MepilexAg in conjunction with conventional clinical treatments in chronic local infectious ulcer
Active Comparator: Dry Ag dressing; Using dry Ag dressing in conjunction with conventional clinical treatments	Device: Dry Ag dressing; Using dry Ag dressing in conjunction with conventional clinical treatments

What is the study measuring?

Primary 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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Long2025-CW-Ag foam dressing

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No