Study objective The purpose of this trial is to evaluate the efficacy and safety of the investigational device, ULSD-12D, as Compared to the comparator, SONOCA-180, in chronic wound.
* Study design Multi-center, randomized clinical trial * Study population Adults with chronic wound * Investigational device treatment procedure Before Treatment: The subject's eligibility (inclusion/exclusion criteria) will be assessed,and apply the Study Device or Comparator on their wound in a randomized manner. Post-Treatment: All subjects will take pictures of the wound area and measured the number of microorganism and wound size.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
wound cleansing and debridement using ULSD-12D
wound cleansing and debridement using SONOCA-180
Samsung Medical Center
Seoul, Gangnam-gu, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Hanyang University Hospital
Seoul, Seongdong-gu, South Korea
The number of microorganisms on wound bed
Investigator measured the number of microorganisms on wound bed at pre and post debridement using nitrocellulose filter.
Time frame: Baseline and 30minuts post debridement
necrotic tissue region
Area calculation of necrotic tissue region at pre and post debridement
Time frame: Baseline and 30minuts post debridement
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