WoundsPhase 3NCT00590369
Negative Pressure Wound Therapy: Are All Systems Alike?
A Phase 3 study testing KCI -VAC and Versatile One (EZCare) in people with Wounds, run by The Cleveland Clinic at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds
- What is being tested?
- KCI -VAC and Versatile One (EZCare)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Aug 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized adults requiring negative pressure dressings.
Who cannot join
- 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
Show all 10Show fewer
- Unexplored fistula
- Necrotic tissue
- Exposed blood vessels or organs
- Untreated malnutrition.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Wounds
- Being tested
- KCI -VAC, Versatile One (EZCare)
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KCI -VACDevice
Negative pressure wound therapy device
Versatile One (EZCare)Device
Negative pressure wound therapy device
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | KCI VAC type negative pressure wound therapy device Receives: Device: KCI -VAC |
| 2 | Experimental | Versatile One (EZCare) negative wound therapy device Receives: Device: Versatile One (EZCare) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: first dressing change; typically within 48 hours
Secondary outcomes (5)
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
Measured: 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
Measured: during hospital stay; generally 6 days
Cost of Wound Care
cost of device/supplies used in application and dressing changes
Measured: during hospital stay; generally 6 days
Nursing Time
Measured: hospital stay; generally 6 days
Patient Reported Pain
scale of 0= no pain to 10= worst pain possible
Measured: at first dressing change; generally 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startJan 2006
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: Recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for WoundsStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Investigators
- Nancy M Albert, PhD, RN, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590369
- Sponsor's protocol ID
- 8309-c
- Other IDs
- OSR 20050803
- Status last verified
- Mar 2012
- First submitted
- 26 Dec 2007
- Last updated
- 2 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Pressure Wound Therapy: Are All Systems Alike?
- ClinicalTrials.gov ID
- NCT00590369
- Acronym / sponsor ID
- 8309-c
- Conditions
- Wounds
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment challenges
- Enrolment
- 11 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- Jan 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 10 Jan 2008 (estimated)
- Results
- Posted 2 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: KCI -VACKCI VAC type negative pressure wound therapy device |
| 2 | Experimental | Device: Versatile One (EZCare)Versatile One (EZCare) negative wound therapy device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized adults requiring negative pressure dressings.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KCI -VACNegative pressure wound therapy device | Device | 1 |
| Versatile One (EZCare)Negative pressure wound therapy device | Device | 2 |
Primary outcome
5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling
Time frame: 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
5 secondary outcomes
Ease of Performing Dressing Change
Time frame: during hospital stay; generally 6 days
Ease of Providing Nursing Care
Time frame: during hospital stay; generally 6 days
Cost of Wound Care
Time frame: during hospital stay; generally 6 days
Nursing Time
Time frame: hospital stay; generally 6 days
Patient Reported Pain
Time frame: at first dressing change; generally 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy M Albert, PhD, RN principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KCI -VAC and Versatile One (EZCare) in people with Wounds, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling (time frame: first dressing change; typically within 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2012.