A RCT of Moist Ag Dressing in Chronic Wound
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University Third Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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**.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Ag foam dressing named MepilexAg
DeviceUsing MepilexAg in conjunction with conventional clinical treatments in chronic local infectious ulcer
Dry Ag dressing
DeviceUsing dry Ag dressing in conjunction with conventional clinical treatments
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: MOIST Ag dressingExperimental treatment 1 intervention
Group B: Dry Ag dressingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
wound area reduction in two weeks
Pre-treatment area minus post-treatment area, then divided by pre-treatment area
Time frame
From enrollment to the end of treatment at 2 weeksSecondary outcomes
1
wound healing rate
Percentage of healed wounds to total cases by D14
Time frame
From enrollment to the end of treatment at 2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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