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Regulated Negative Pressure-Assisted Wound Therapy Device

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ClinicalTrials.gov Identifier: NCT01603901
Recruitment Status : Unknown
Verified May 2012 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 23, 2012
Last Update Posted : May 23, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Negative-Pressure Wound Therapy Device: Regulated Negative Pressure-Assisted Wound Therapy Device

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2012
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Efficacy [ Time Frame: Ten days ]
    Measurement of change in wound size


Eligibility Criteria

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 Posted: May 23, 2012    Key Record Dates
Last Update Posted: May 23, 2012
Last Verified: May 2012