Clinical Trial to Evaluate Ultrasonic Surgical Device in Chronic Pressure Ulcer

Not Applicable

Completed

• Conditions: Necrosis; Wound; Pressure Ulcer
• Interventions: Device: SONOCA-180; Device: ULSD-12D

• Registration Number: NCT02007824
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-10-31
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-11
• Primary Completion: 2014-02
• Study Completion: 2014-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-04
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

• cellulitis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SONOCA-180	SONOCA-180	ultrasound surgical device made by Soering
ULSD-12D	ULSD-12D	ultrasound surgical device made by Ultech.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
necrotic tissue region	Baseline and 30minuts post debridement	Area calculation of necrotic tissue region at pre and post debridement

Trial Locations

Locations (3)

Samsung Medical Center; 🇰🇷 Seoul, Gangnam-gu, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

Hanyang University Hospital; 🇰🇷 Seoul, Seongdong-gu, Korea, Republic of