Efficacy of Novel Blue Silver Nanoparticles Hydrogel versus Reference Hydrogel: A Prospective Randomized Controlled Trial for Acute and Chronic Wound Management
- Conditions
- Patients who have acute or chronic partial- or full- thickness wounds and wounds due to thermal burns and accidental injury were included.Acute or chronic woundsPartial or full thickness wound
- Registration Number
- TCTR20230623001
- Lead Sponsor
- ovatec Healthcare Co.,Ltd.
- Brief Summary
The blue AgNPs and reference hydrogels were comparable in terms of wound area reduction and pain scores during the changing of wound dressings, with no significant differences. Patients in the blue AgNPs hydrogel group showed low rates of bacterial infection for both gram-negative and gram-positive strains; in particular, there was almost complete prevention of infection by gram-positive strains at day 21 after treatment initiation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 62
1. All participants were required to be more than 10 years of age and have acute or chronic partial- or full-thickness wounds
2. wounds due to thermal burns and accidental injury were included.
1. Patients were pregnant, allergic to hydrogel or silver.
2. Patients had a compromised immune system, or had any other connective tissue disease.
3. Infected wounds with frank pus or necrotic tissues were also excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method wound area reduction (wound healing) on days 0, 7, 14, and 21 after treatment initiation % wound area reduction
- Secondary Outcome Measures
Name Time Method pain intensity on days 0, 7, 14, and 21 after treatment initiation 10-point visual analogue scale score,infection prevention at day 0, 7, 14, and 21 after treatment initiation wound swab culture