Necrosis, Pressure Ulcer, Wound
Conditions
Keywords
pressure ulcer, chronic wound, tissue necrosis, slough, ultra sound
Brief summary
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.
Detailed description
* 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.
Interventions
DEVICEULSD-12D
wound cleansing and debridement using ULSD-12D
DEVICESONOCA-180
wound cleansing and debridement using SONOCA-180
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* over 20 years of age * subject who has untreated wounds * subject who has wound size over 3cm x 3cm * subject who has wound over stage 2
Exclusion criteria
* cellulitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of microorganisms on wound bed | Baseline and 30minuts post debridement | Investigator measured the number of microorganisms on wound bed at pre and post debridement using nitrocellulose filter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| necrotic tissue region | Baseline and 30minuts post debridement | Area calculation of necrotic tissue region at pre and post debridement |
Countries
South Korea
Outcome results
None listed