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Clinical Trial to Evaluate Ultrasonic Surgical Device in Chronic Pressure Ulcer

Pressure Ulcer Clinical Trial

Official title:
Clinical Trial to Evaluate Efficacy and Safety of Ultrasonic Surgical Device (ULSC-12D)in Chronic Pressure Ulcer

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02007824
Study type Interventional
Source Seoul National University Hospital
Contact
Status Completed
Phase N/A
Start date August 2013
Completion date March 2014
View Details
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