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NCT02007824 Clinical Trial

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 Details — Status: Completed

Administrative data
NCT number NCT02007824
Other study ID # 08-2013-020
Secondary ID ULSC-12D
Status Completed
Phase N/A
First received October 31, 2013
Last updated April 4, 2014
Start date August 2013
Est. completion date March 2014

Study information
Verified date April 2014
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Education, Science, and Technology
Study type Interventional

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date March 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Device:
• ULSD-12D
wound cleansing and debridement using ULSD-12D
• SONOCA-180
wound cleansing and debridement using SONOCA-180

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do
Korea, Republic of Hanyang University Hospital Seoul Seongdong-gu
Korea, Republic of Samsung Medical Center Seoul Gangnam-gu

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The number of microorganisms on wound bed Investigator measured the number of microorganisms on wound bed at pre and post debridement using nitrocellulose filter. Baseline and 30minuts post debridement No
Secondary necrotic tissue region Area calculation of necrotic tissue region at pre and post debridement Baseline and 30minuts post debridement No
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