Regulated Negative Pressure-Assisted Wound Therapy Device

This study is not yet open for participant recruitment.
Verified May 2012 by Hillel Yaffe Medical Center
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01603901
First received: May 20, 2012
Last updated: May 22, 2012
Last verified: May 2012
  Purpose

Regulated negative pressure-assisted wound therapy (RNPT) is regarded as a gold standard technology for treatment of various chronic and acute wounds. The investigators plan to evaluate the efficacy and ease of use of this device.


Condition Intervention
Negative-Pressure Wound Therapy
Device: Regulated Negative Pressure-Assisted Wound Therapy Device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Efficacy [ Time Frame: Ten days ] [ Designated as safety issue: No ]
    Measurement of change in wound size


Estimated Enrollment: 10
Study Start Date: June 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigated Wounds Device: Regulated Negative Pressure-Assisted Wound Therapy Device
Negative pressure will be applied in the usual way that is normally applied in our Medical Center

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic or acute wounds

Exclusion Criteria:

  • Uncontrolled bleeding
  • Neoplasms in wound
  • Exposed blood vessels
  • Exposed internal organs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603901

Contacts
Contact: Moris Topaz, MD, PhD 972-4-6304689 plastic_surg@hy.health.gov.il

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Principal Investigator: Moris Topaz, MD, PhD         
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01603901     History of Changes
Other Study ID Numbers: HYMC-2012-31
Study First Received: May 20, 2012
Last Updated: May 22, 2012
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on April 17, 2014