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
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 April 17, 2014