Clinical Trial to Evaluate Ultrasonic Surgical Device in Chronic Pressure Ulcer

Seoul National University

Status: Completed

Conditions: Wound; Pressure Ulcer; Necrosis

Treatments: Device: SONOCA-180; Device: ULSD-12D

Study type: Interventional

Funder types: Other

Identifiers

NCT02007824

08-2013-020

ULSC-12D (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

ULSD-12D

Experimental group

Description:

ultrasound surgical device made by Ultech.

Treatment:

Device: ULSD-12D

SONOCA-180

Active Comparator group

Description:

ultrasound surgical device made by Soering

Treatment:

Device: SONOCA-180