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Sponsors and Collaborators: |
The Cleveland Clinic Smith & Nephew, Inc. |
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Information provided by: | The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT00583141 |
Hypotheses: (1)Wound healing during hospital stay will be equal between systems, (2)RNs will perceive the Versatile One (EZCare) system as easier to use, (3)Costs related to dressing changes will be less with Versatile one (EZCare), (4)Hospital length of stay will be equal or shorter with the Versatile One (EzCare) system, (5) Nursing time using Versatile One (EZCare) will be less than or equal to VAC system, (6) Patients will report less pain during dressing changes with Versatile One (EZCare).
Condition | Intervention | Phase |
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Wounds |
Device: KCI -VAC Device: Versatile One (EZCare) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Factorial Assignment |
Official Title: | Negative Pressure Wound Therapy: Are All Systems Alike? |
Estimated Enrollment: | 50 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
KCI VAC type negative pressure wound therapy device
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Device: KCI -VAC
Negative pressure wound therapy device
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2: Experimental
Versatile One (EZCare)negative wound therapy device
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Device: Versatile One (EZCare)
Negative pressure wound therapy device
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This is a prospective, 2 group, randomized, comparative study (sample:50; 25 in each group) that will investigate whether differences can be found in selected outcomes related to wound care, using Versatile One (EZCare)versus KCI VAC negative pressure/vacuum systems. Only wounds which currently meet criteria for such device use,and for which a physician's order has been written for the device, will be included in this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Patricia A Adler, PhD, RN | 216-221-6807 | adlerp@ccf.org |
Contact: Nancy Albert, PhD, RN | 216-445-0905 | albertn@ccf.org |
United States, Ohio | |
Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44107 | |
Contact: Patricia A Adler, PhD, RN 216-445-3457 adlerp@ccf.org | |
Contact: Nancy Albert, PhD, RN 216-445-0905 albertn@ccf.org | |
Principal Investigator: Patricia A Adler, PhD, RN |
Principal Investigator: | Patricia A Adler, PhD, RN | Cleveland Clinic |
Responsible Party: | Cleveland Clinic ( Patricia A. Adler, PhD, RN ) |
Study ID Numbers: | 8309, OSR 20050803 |
Study First Received: | December 26, 2007 |
Last Updated: | December 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00583141 |
Health Authority: | United States: Institutional Review Board |