A RCT of Moist Ag Dressing in Chronic Wound

Peking University

Status: Not yet enrolling

Conditions: Wound he'a'Ling; Chronic Wound; Dressing; Wound Healing; Hard to Heal Wounds

Treatments: Device: Dry Ag dressing; Device: Ag foam dressing named MepilexAg

Study type: Interventional

Funder types: Other

Identifiers

NCT07235254

Long2025-CW-Ag foam dressing

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

MOIST Ag dressing

Experimental group

Description:

Using MepilexAg in conjunction with conventional clinical treatments

Treatment:

Device: Ag foam dressing named MepilexAg

Dry Ag dressing

Active Comparator group

Description:

Using dry Ag dressing in conjunction with conventional clinical treatments

Treatment:

Device: Dry Ag dressing