Clinical Trial to Evaluate Ultrasonic Surgical Device in... | NCT02007824

Studies
Clinical Trial to Evaluate Ultrasonic Surgical Device in Chronic Pressure Ulcer

NCT02007824

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Apr 7, 2014Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Pressure Ulcer
Wound
Necrosis

Interventions

ULSD-12D
SONOCA-180

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ULSC-12D	Other Identifier	Ultech Ltd.

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Feb 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Oct 31, 2013

First Submission Date that Met QC Criteria

Dec 5, 2013

First Posted Date

Dec 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2014

Last Update Posted Date

Apr 7, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chan-Yeong Heo, Assistant professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ULSD-12D	Experimental	ultrasound surgical device made by Ultech.	Device: ULSD-12D
SONOCA-180	Active Comparator	ultrasound surgical device made by Soering	Device: SONOCA-180

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ULSD-12D	Device	wound cleansing and debridement using ULSD-12D	ULSD-12D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of microorganisms on wound bed	Investigator measured the number of microorganisms on wound bed at pre and post debridement using nitrocellulose filter.	Baseline and 30minuts post debridement

Secondary Outcomes

Measure	Description	Time Frame
necrotic tissue region	Area calculation of necrotic tissue region at pre and post debridement	Baseline and 30minuts post debridement

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chanyeong - Heo, Ph.D	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul	Gangnam-gu	135-710	South Korea
Seoul National University Bundang Hospital

Condition Browse Module

MeSH Terms

ID	Term
D003668	Pressure Ulcer
D014947	Wounds and Injuries
D009336	Necrosis

Ancestor Terms

ID	Term
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided