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Clinical Trials/NCT02007824
NCT02007824CompletedNot Applicable

Clinical Trial to Evaluate Efficacy and Safety of Ultrasonic Surgical Device (ULSC-12D)in Chronic Pressure Ulcer

Seoul National University Hospital3 sites in 1 country30 target enrollmentStarted: August 1, 2013Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
3
Primary Endpoint
The number of microorganisms on wound bed
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

ULSD-12D

Experimental

ultrasound surgical device made by Ultech.

Intervention: ULSD-12D (Device)

SONOCA-180

Active Comparator

ultrasound surgical device made by Soering

Intervention: SONOCA-180 (Device)

Outcomes

Primary Outcomes

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 Outcomes

  • necrotic tissue region(Baseline and 30minuts post debridement)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chan-Yeong Heo

Assistant professor

Seoul National University Hospital

Study Sites (3)

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