Regulated Negative Pressure-Assisted Wound Therapy Device

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014