NCT02007824

Clinical Trial to Evaluate Ultrasonic Surgical Device in Chronic Pressure Ulcer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pressure Ulcer
• Wound
• Necrosis

Interventions

Type	Name	Description
DEVICE	ULSD-12D	wound cleansing and debridement using ULSD-12D
DEVICE	SONOCA-180	wound cleansing and debridement using SONOCA-180

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-02-01
• Completion: 2014-03-01
• First posted: 2013-12-11
• Last updated: 2014-04-07

Locations

3 sites across 1 country: South Korea