Study Stopped
Recruitment challenges
Negative Pressure Wound Therapy: Are All Systems Alike?
2 other identifiers
interventional
11
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2006
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
April 2, 2012
CompletedApril 2, 2012
March 1, 2012
2.6 years
December 26, 2007
June 22, 2011
March 30, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling
differences in wound healing rate at first dressing between devices; since 5 variables were assessed via a centimeter ruler
first dressing change; typically within 48 hours
Secondary Outcomes (5)
Ease of Performing Dressing Change
during hospital stay; generally 6 days
Ease of Providing Nursing Care
during hospital stay; generally 6 days
Cost of Wound Care
during hospital stay; generally 6 days
Nursing Time
hospital stay; generally 6 days
Patient Reported Pain
at first dressing change; generally 48 hours
Study Arms (2)
1
ACTIVE COMPARATORKCI VAC type negative pressure wound therapy device
2
EXPERIMENTALVersatile One (EZCare) negative wound therapy device
Interventions
Eligibility Criteria
You may qualify if:
- Hospitalized adults requiring negative pressure dressings.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Cleveland Cliniclead
- Smith & Nephew, Inc.collaborator
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44107, United States
MeSH Terms
Conditions
Limitations and Caveats
small sample size; early termination; did not reach expected sample size. Single center
Results Point of Contact
- Title
- Nancy M. Albert PhD, RN
- Organization
- Cleveland Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy M Albert, PhD, RN
The Cleveland Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 26, 2007
First Posted
January 10, 2008
Study Start
January 1, 2006
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
April 2, 2012
Results First Posted
April 2, 2012
Record last verified: 2012-03