Back to resultsRegulated Negative Pressure-Assisted Wound Therapy Device
Primary Purpose
Negative-Pressure Wound Therapy
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Regulated Negative Pressure-Assisted Wound Therapy Device
Sponsored by
About this trial
This is an interventional treatment trial for Negative-Pressure Wound Therapy
Eligibility Criteria
Inclusion Criteria:
- Chronic or acute wounds
Exclusion Criteria:
- Uncontrolled bleeding
- Neoplasms in wound
- Exposed blood vessels
- Exposed internal organs
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Investigated Wounds
Arm Description
Outcomes
Primary Outcome Measures
Efficacy
Measurement of change in wound size
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01603901
Brief Title
Regulated Negative Pressure-Assisted Wound Therapy Device
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
May 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Negative-Pressure Wound Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Investigated Wounds
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Regulated Negative Pressure-Assisted Wound Therapy Device
Intervention Description
Negative pressure will be applied in the usual way that is normally applied in our Medical Center
Primary Outcome Measure Information:
Title
Efficacy
Description
Measurement of change in wound size
Time Frame
Ten days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic or acute wounds
Exclusion Criteria:
Uncontrolled bleeding
Neoplasms in wound
Exposed blood vessels
Exposed internal organs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moris Topaz, MD, PhD
Phone
972-4-6304689
Email
plastic_surg@hy.health.gov.il
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moris Topaz, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Regulated Negative Pressure-Assisted Wound Therapy Device
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