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Completed

NCT Number: NCT02007824

Clinical Trial to Evaluate Ultrasonic Surgical Device in Chronic Pressure Ulcer

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.

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Key information

Conditions

Pressure Ulcer Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Wound Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center, Seoul, Gangnam-gu, South Korea

Loading trial locations.

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ULSD-12D

Device

wound cleansing and debridement using ULSD-12D

SONOCA-180

Device

wound cleansing and debridement using SONOCA-180

Primary outcomes

  1. 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

  1. necrotic tissue region

    Time frame: Baseline and 30minuts post debridement

    Area calculation of necrotic tissue region at pre and post debridement

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 11, 2013
Registry last updated
Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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