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Clinical Trial to Evaluate Ultrasonic Surgical Device in Chronic Pressure Ulcer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02007824
First Posted: December 11, 2013
Last Update Posted: April 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chan-Yeong Heo, Seoul National University Hospital
  Purpose
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.

Condition Intervention
Pressure Ulcer Wound Necrosis Device: ULSD-12D Device: SONOCA-180

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate Efficacy and Safety of Ultrasonic Surgical Device (ULSC-12D)in Chronic Pressure Ulcer

Resource links provided by NLM:


Further study details as provided by Chan-Yeong Heo, Seoul National University Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • necrotic tissue region [ Time Frame: Baseline and 30minuts post debridement ]
    Area calculation of necrotic tissue region at pre and post debridement


Enrollment: 30
Study Start Date: August 2013
Study Completion Date: March 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ULSD-12D
ultrasound surgical device made by Ultech.
Device: ULSD-12D
wound cleansing and debridement using ULSD-12D
Active Comparator: SONOCA-180
ultrasound surgical device made by Soering
Device: SONOCA-180
wound cleansing and debridement using SONOCA-180

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007824


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Gangnam-gu, Korea, Republic of, 135-710
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Hanyang University Hospital
Seoul, Seongdong-gu, Korea, Republic of, 133-791
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Chanyeong - Heo, Ph.D Seoul National University Bundang Hospital
  More Information

Responsible Party: Chan-Yeong Heo, Assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02007824     History of Changes
Other Study ID Numbers: 08-2013-020
ULSC-12D ( Other Identifier: Ultech Ltd. )
First Submitted: October 31, 2013
First Posted: December 11, 2013
Last Update Posted: April 7, 2014
Last Verified: April 2014

Keywords provided by Chan-Yeong Heo, Seoul National University Hospital:
pressure ulcer
chronic wound
tissue necrosis
slough
ultra sound

Additional relevant MeSH terms:
Ulcer
Necrosis
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases