Wounds
Conditions
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).
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.
Interventions
DEVICEKCI -VAC
Negative pressure wound therapy device
DEVICEVersatile One (EZCare)
Negative pressure wound therapy device
Sponsors
Smith & Nephew, Inc.
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling | first dressing change; typically within 48 hours | differences in wound healing rate at first dressing between devices; since 5 variables were assessed via a centimeter ruler |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Pain | at first dressing change; generally 48 hours | scale of 0= no pain to 10= worst pain possible |
| Ease of Performing Dressing Change | during hospital stay; generally 6 days | 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 |
| Ease of Providing Nursing Care | during hospital stay; generally 6 days | 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 |
| Cost of Wound Care | during hospital stay; generally 6 days | cost of device/supplies used in application and dressing changes |
| Nursing Time | hospital stay; generally 6 days | — |
Countries
United States
Participant flow
Recruitment details
Jan 2006-March 2008; study recruitment; study stopped due to slow enrollment rate
Participants by arm
| Arm | Count |
|---|---|
| KCI VAC KCI VAC type negative pressure wound therapy device | 6 |
| Versatile One Versatile One (EZCare)negative wound therapy device | 5 |
| Total | 11 |
Baseline characteristics
| Characteristic | Versatile One | KCI VAC | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 6 Participants | 10 Participants |
| Age Continuous median | 49 years | 57 years | 50 years |
| Region of Enrollment United States | 5 participants | 6 participants | 11 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 |
Outcome results
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
Time frame: first dressing change; typically within 48 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| KCI VAC | 5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling | Length of wound | 10.6 centimeters |
| KCI VAC | 5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling | Undermining of wound | 0 centimeters |
| KCI VAC | 5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling | Width of wound | 2.75 centimeters |
| KCI VAC | 5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling | Tunneling of wound | 0 centimeters |
| KCI VAC | 5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling | Depth of wound | 2.5 centimeters |
| Versatile One | 5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling | Tunneling of wound | 0 centimeters |
| Versatile One | 5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling | Depth of wound | 2.2 centimeters |
| Versatile One | 5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling | Length of wound | 16.5 centimeters |
| Versatile One | 5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling | Width of wound | 4.2 centimeters |
| Versatile One | 5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling | Undermining of wound | 0 centimeters |
Secondary
Cost of Wound Care
cost of device/supplies used in application and dressing changes
Time frame: during hospital stay; generally 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KCI VAC | Cost of Wound Care | 510.18 dollars (USD) | Standard Deviation 419.77 |
| Versatile One | Cost of Wound Care | 333.54 dollars (USD) | Standard Deviation 71.69 |
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
Time frame: during hospital stay; generally 6 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| KCI VAC | Ease of Performing Dressing Change | 8.5 scores on a scale |
| Versatile One | Ease of Performing Dressing Change | 6.0 scores on a scale |
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
Time frame: during hospital stay; generally 6 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| KCI VAC | Ease of Providing Nursing Care | 10 scores on a scale |
| Versatile One | Ease of Providing Nursing Care | 8.0 scores on a scale |
Secondary
Nursing Time
Time frame: hospital stay; generally 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KCI VAC | Nursing Time | 33.2 minutes | Standard Deviation 23.8 |
| Versatile One | Nursing Time | 38.8 minutes | Standard Deviation 19.9 |
Secondary
Patient Reported Pain
scale of 0= no pain to 10= worst pain possible
Time frame: at first dressing change; generally 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KCI VAC | Patient Reported Pain | 3.2 units on a scale | Standard Deviation 3.7 |
| Versatile One | Patient Reported Pain | 2.4 units on a scale | Standard Deviation 2.3 |