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Clinical Trial to Evaluate Ultrasonic Surgical Device in Chronic Pressure Ulcer

Primary Purpose

Pressure Ulcer, Wound, Necrosis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ULSD-12D
SONOCA-180
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure Ulcer focused on measuring pressure ulcer, chronic wound, tissue necrosis, slough, ultra sound

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center
  • Seoul National University Bundang Hospital
  • Hanyang University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ULSD-12D

SONOCA-180

Arm Description

ultrasound surgical device made by Ultech.

ultrasound surgical device made by Soering

Outcomes

Primary Outcome Measures

The number of microorganisms on wound bed
Investigator measured the number of microorganisms on wound bed at pre and post debridement using nitrocellulose filter.

Secondary Outcome Measures

necrotic tissue region
Area calculation of necrotic tissue region at pre and post debridement

Full Information

First Posted
October 31, 2013
Last Updated
April 4, 2014
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02007824
Brief Title
Clinical Trial to Evaluate Ultrasonic Surgical Device in Chronic Pressure Ulcer
Official Title
Clinical Trial to Evaluate Efficacy and Safety of Ultrasonic Surgical Device (ULSC-12D)in Chronic Pressure Ulcer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Wound, Necrosis
Keywords
pressure ulcer, chronic wound, tissue necrosis, slough, ultra sound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ULSD-12D
Arm Type
Experimental
Arm Description
ultrasound surgical device made by Ultech.
Arm Title
SONOCA-180
Arm Type
Active Comparator
Arm Description
ultrasound surgical device made by Soering
Intervention Type
Device
Intervention Name(s)
ULSD-12D
Intervention Description
wound cleansing and debridement using ULSD-12D
Intervention Type
Device
Intervention Name(s)
SONOCA-180
Intervention Description
wound cleansing and debridement using SONOCA-180
Primary Outcome Measure Information:
Title
The number of microorganisms on wound bed
Description
Investigator measured the number of microorganisms on wound bed at pre and post debridement using nitrocellulose filter.
Time Frame
Baseline and 30minuts post debridement
Secondary Outcome Measure Information:
Title
necrotic tissue region
Description
Area calculation of necrotic tissue region at pre and post debridement
Time Frame
Baseline and 30minuts post debridement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chanyeong - Heo, Ph.D
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Hanyang University Hospital
City
Seoul
State/Province
Seongdong-gu
ZIP/Postal Code
133-791
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial to Evaluate Ultrasonic Surgical Device in Chronic Pressure Ulcer

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