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

May 20, 2012
May 22, 2012
June 2012
August 2012   (final data collection date for primary outcome measure)
Efficacy [ Time Frame: Ten days ] [ Designated as safety issue: No ]
Measurement of change in wound size
Same as current
Complete list of historical versions of study NCT01603901 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Regulated Negative Pressure-Assisted Wound Therapy Device
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Negative-Pressure Wound Therapy
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
Experimental: Investigated Wounds
Intervention: Device: Regulated Negative Pressure-Assisted Wound Therapy Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
10
May 2013
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic or acute wounds

Exclusion Criteria:

  • Uncontrolled bleeding
  • Neoplasms in wound
  • Exposed blood vessels
  • Exposed internal organs
Both
16 Years and older
No
Contact: Moris Topaz, MD, PhD 972-4-6304689 plastic_surg@hy.health.gov.il
Israel
 
NCT01603901
HYMC-2012-31
Yes
Hillel Yaffe Medical Center
Hillel Yaffe Medical Center
Not Provided
Not Provided
Hillel Yaffe Medical Center
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP