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Regulated Negative Pressure-Assisted Wound Therapy Device

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01603901
First Posted: May 23, 2012
Last Update Posted: May 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Efficacy [ Time Frame: Ten days ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01603901     History of Changes
Other Study ID Numbers: HYMC-2012-31
First Submitted: May 20, 2012
First Posted: May 23, 2012
Last Update Posted: May 23, 2012
Last Verified: May 2012