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NCT Number: NCT07235254

A RCT of Moist Ag Dressing in Chronic Wound

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Ag foam dressing named MepilexAg

Device

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

Dry Ag dressing

Device

Using dry Ag dressing in conjunction with conventional clinical treatments

Primary outcomes

  1. wound area reduction in two weeks

    Time frame: From enrollment to the end of treatment at 2 weeks

    Pre-treatment area minus post-treatment area, then divided by pre-treatment area

Secondary outcomes

  1. wound healing rate

    Time frame: From enrollment to the end of treatment at 2 weeks

    Percentage of healed wounds to total cases by D14

Study contacts

Contact information is provided by the study sponsor or research team.

Long Zhang Executive Deputy Director, Medical Doctor

CONTACT

[email protected]

+86 010-82266699

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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