Negative Pressure Wound Therapy: Are All Systems Alike?

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Negative Pressure Wound Therapy: Are All Systems Alike?

Conditions
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Wounds

Intervention / Treatment
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* Device: KCI -VAC
* Device: Versatile One (EZCare)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>KCI VAC type negative pressure wound therapy device | Device: KCI -VAC<br>* Negative pressure wound therapy device<br>|
| Experimental: 2<br>Versatile One (EZCare) negative wound therapy device | Device: Versatile One (EZCare)<br>* Negative pressure wound therapy device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |