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Clinical Trial to Evaluate Ultrasonic Surgical Device in Chronic Pressure Ulcer

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ClinicalTrials.gov Identifier: NCT02007824
Recruitment Status : Completed
First Posted : December 11, 2013
Last Update Posted : April 7, 2014
Sponsor:
Information provided by (Responsible Party):
Chan-Yeong Heo, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Pressure Ulcer Wound Necrosis Device: ULSD-12D Device: SONOCA-180 Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : August 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. necrotic tissue region [ Time Frame: Baseline and 30minuts post debridement ]
    Area calculation of necrotic tissue region at pre and post debridement



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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

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

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 Posted: December 11, 2013    Key Record Dates
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