A RCT of Moist Ag Dressing in Chronic Wound

NCT07235254 | Not Yet Recruiting DMC

• 1 other identifier: Long2025-CW-Ag foam dressing
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Wound; Hard to Heal Wounds; Dressing; Wound Healing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• wound healing rate

  From enrollment to the end of treatment at 2 weeks

Study Arms (2)

MOIST Ag dressing

EXPERIMENTAL

Using MepilexAg in conjunction with conventional clinical treatments

Device: Ag foam dressing named MepilexAg

Dry Ag dressing

ACTIVE COMPARATOR

Using dry Ag dressing in conjunction with conventional clinical treatments

Device: Dry Ag dressing

Interventions

Ag foam dressing named MepilexAg DEVICE

Using MepilexAg in conjunction with conventional clinical treatments in chronic local infectious ulcer

MOIST Ag dressing

Dry Ag dressing DEVICE

Using dry Ag dressing in conjunction with conventional clinical treatments

Dry Ag dressing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Central Study Contacts

Long Zhang Executive Deputy Director, Medical Doctor

CONTACT

+86 010-82266699; longzh2000@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Wound Healing Center

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

CN (1)