Clinical Trial to Evaluate Efficacy and Safety of Ultrasonic Surgical Device (ULSC-12D)in Chronic Pressure Ulcer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pressure Ulcer
- Sponsor
- Seoul National University Hospital
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- The number of microorganisms on wound bed
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Chan-Yeong Heo
Assistant professor
Seoul National University Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
The number of microorganisms on wound bed
Time Frame: Baseline and 30minuts post debridement
Investigator measured the number of microorganisms on wound bed at pre and post debridement using nitrocellulose filter.
Secondary Outcomes
- necrotic tissue region(Baseline and 30minuts post debridement)