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:
Hillel Yaffe Medical Center
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
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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
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 May 16, 2013