A RCT of Moist Ag Dressing in Chronic Wound

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-09-01

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MOIST Ag dressing

Using MepilexAg in conjunction with conventional clinical treatments

Group Type EXPERIMENTAL

Ag foam dressing named MepilexAg

Intervention Type DEVICE

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

Dry Ag dressing

Using dry Ag dressing in conjunction with conventional clinical treatments

Group Type ACTIVE_COMPARATOR

Dry Ag dressing

Intervention Type DEVICE

Using dry Ag dressing in conjunction with conventional clinical treatments

Interventions

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Ag foam dressing named MepilexAg

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

Intervention Type DEVICE

Dry Ag dressing

Using dry Ag dressing in conjunction with conventional clinical treatments

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No