Clinical Trial to Evaluate Ultrasonic Surgical Device in Chronic Pressure Ulcer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chan-Yeong Heo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02007824
First received: October 31, 2013
Last updated: April 4, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Seoul National University Hospital:

Primary Outcome Measures:
  • The number of microorganisms on wound bed [ Time Frame: Baseline and 30minuts post debridement ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 31, 2013
Last Updated: April 4, 2014
Health Authority: Korea: Ministry of Education, Science, and Technology

Keywords provided by Seoul National University Hospital:
pressure ulcer
chronic wound
tissue necrosis
slough
ultra sound

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

ClinicalTrials.gov processed this record on August 20, 2014