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Negative Pressure Wound Therapy: Are All Systems Alike?
This study is currently recruiting participants.
Verified by The Cleveland Clinic, December 2007
Sponsors and Collaborators: The Cleveland Clinic
Smith & Nephew, Inc.
Information provided by: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00590369
  Purpose

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
Wounds
 Device: KCI -VAC
Device: Versatile One (EZCare)
 Phase III

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Factorial Assignment
Official Title: Negative Pressure Wound Therapy: Are All Systems Alike?

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Wound Healing [ Time Frame: hospital stay ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ease of performing dressing change [ Time Frame: hospital stay ] [ Designated as safety issue: Yes ]
  • Ease of providing nursing care [ Time Frame: hospital stay ] [ Designated as safety issue: Yes ]
  • Cost of wound care [ Time Frame: hospital stay ] [ Designated as safety issue: Yes ]
  • Hospital length of stay [ Time Frame: hospital stay ] [ Designated as safety issue: Yes ]
  • Nursing time [ Time Frame: hospital stay ] [ Designated as safety issue: Yes ]
  • Patient reported pain [ Time Frame: hospital stay ] [ Designated as safety issue: Yes ]

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
1: Active Comparator
KCI VAC type negative pressure wound therapy device
Device: KCI -VAC
Negative pressure wound therapy device
2: Experimental
Versatile One (EZCare)negative wound therapy device
Device: Versatile One (EZCare)
Negative pressure wound therapy device

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized adults requiring negative pressure dressings.

Exclusion Criteria:

  • Comatose
  • Mentally obtunded
  • Documented chronic psychiatric illness or any documented dementia significant enough to notably impair cognitive function
  • Presence of Manufacturer's contraindications
  • Malignancy in wound
  • Untreated osteomyelitis
  • Unexplored fistula
  • Necrotic tissue
  • Exposed blood vessels or organs
  • Untreated malnutrition.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00590369

Contacts
Contact: Patricia A Adler, PhD, RN 216-221-6807 adlerp@ccf.org
Contact: Nancy Albert, PhD, RN 216-445-0905 albertn@ccf.org

Locations
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            
Sponsors and Collaborators
The Cleveland Clinic
Smith & Nephew, Inc.
Investigators
Principal Investigator: Patricia A Adler, PhD, RN Cleveland Clinic
  More Information

Responsible Party: Cleveland Clinic ( Patricia A. Adler, PhD, RN )
Study ID Numbers: 8309-c, OSR 20050803
Study First Received: December 26, 2007
Last Updated: January 9, 2008
ClinicalTrials.gov Identifier: NCT00590369  
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on January 16, 2009



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