| ID | Type | Description | Link |
|---|---|---|---|
| OSR 20050803 |
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Recruitment challenges
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| Name | Class |
|---|---|
| Smith & Nephew, Inc. | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | KCI VAC type negative pressure wound therapy device |
|
| 2 | Experimental | Versatile One (EZCare) negative wound therapy device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KCI -VAC | Device | Negative pressure wound therapy device |
| |
| Versatile One (EZCare) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Performing Dressing Change | responses to questions using a Likert scale regarding ease of dressing change; 8 characteristics; only reported is: Apply/fasten occlusive drape to secure drainage tube; scale range is 0, very difficult to do, takes a lot of time or effort or not possible to 10, simple or very easy to do | during hospital stay; generally 6 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy M Albert, PhD, RN | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44107 | United States |
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Jan 2006-March 2008; study recruitment; study stopped due to slow enrollment rate
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| ID | Title | Description |
|---|---|---|
| FG000 | KCI VAC | KCI VAC type negative pressure wound therapy device |
| FG001 | Versatile One | Versatile One (EZCare)negative wound therapy device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | KCI VAC | KCI VAC type negative pressure wound therapy device |
| BG001 | Versatile One | Versatile One (EZCare)negative wound therapy device |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Jun 2011 | Median | Inter-Quartile Range | centimeters | first dressing change; typically within 48 hours |
|
duration of patient enrollment- generally 6 days; serious and/or other [non-serious] adverse events were collected/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KCI VAC | KCI VAC type negative pressure wound therapy device |
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small sample size; early termination; did not reach expected sample size. Single center
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy M. Albert PhD, RN | Cleveland Clinic | 216-444-7028 | albertn@ccf.org |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Device |
Negative pressure wound therapy device |
|
| Ease of Providing Nursing Care | nurse perception of ease of providing nursing care using a Likert-type scale; 5 items assessed. Responses to 1 item provided: Overall experience with nursing care issues related to the wound device. score range is 0, always very difficult, always a problem or not possible to 10, always easy, never or rarely a problem | during hospital stay; generally 6 days |
| Cost of Wound Care | cost of device/supplies used in application and dressing changes | during hospital stay; generally 6 days |
| Nursing Time | hospital stay; generally 6 days |
| Patient Reported Pain | scale of 0= no pain to 10= worst pain possible | at first dressing change; generally 48 hours |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Secondary | Ease of Performing Dressing Change | responses to questions using a Likert scale regarding ease of dressing change; 8 characteristics; only reported is: Apply/fasten occlusive drape to secure drainage tube; scale range is 0, very difficult to do, takes a lot of time or effort or not possible to 10, simple or very easy to do | Posted | Jun 2011 | Median | Inter-Quartile Range | scores on a scale | during hospital stay; generally 6 days |
|
|
|
| Secondary | Ease of Providing Nursing Care | nurse perception of ease of providing nursing care using a Likert-type scale; 5 items assessed. Responses to 1 item provided: Overall experience with nursing care issues related to the wound device. score range is 0, always very difficult, always a problem or not possible to 10, always easy, never or rarely a problem | Posted | Jun 2011 | Median | Inter-Quartile Range | scores on a scale | during hospital stay; generally 6 days |
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|
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| Secondary | Cost of Wound Care | cost of device/supplies used in application and dressing changes | Posted | Jun 2011 | Mean | Standard Deviation | dollars (USD) | during hospital stay; generally 6 days |
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| Secondary | Nursing Time | Posted | Jun 2011 | Mean | Standard Deviation | minutes | hospital stay; generally 6 days |
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| Secondary | Patient Reported Pain | scale of 0= no pain to 10= worst pain possible | Posted | Jun 2011 | Mean | Standard Deviation | units on a scale | at first dressing change; generally 48 hours |
|
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| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Versatile One | Versatile One (EZCare)negative wound therapy device | 0 | 5 | 0 | 5 |
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