Negative Pressure Wound Therapy: Are All Systems Alike?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00590369
Recruitment Status : Terminated (Recruitment challenges)
First Posted : January 10, 2008
Results First Posted : April 2, 2012
Last Update Posted : April 2, 2012
Smith & Nephew, Inc.
Information provided by:
The Cleveland Clinic

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).

Condition or disease Intervention/treatment Phase
Wounds Device: KCI -VAC Device: Versatile One (EZCare) Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Negative Pressure Wound Therapy: Are All Systems Alike?
Study Start Date : January 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
KCI VAC type negative pressure wound therapy device
Device: KCI -VAC
Negative pressure wound therapy device

Experimental: 2
Versatile One (EZCare) negative wound therapy device
Device: Versatile One (EZCare)
Negative pressure wound therapy device

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Ease of Performing Dressing Change [ Time Frame: 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

  2. Ease of Providing Nursing Care [ Time Frame: 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

  3. Cost of Wound Care [ Time Frame: during hospital stay; generally 6 days ]
    cost of device/supplies used in application and dressing changes

  4. Nursing Time [ Time Frame: hospital stay; generally 6 days ]
  5. Patient Reported Pain [ Time Frame: at first dressing change; generally 48 hours ]
    scale of 0= no pain to 10= worst pain possible

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00590369

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44107
Sponsors and Collaborators
The Cleveland Clinic
Smith & Nephew, Inc.
Principal Investigator: Nancy M Albert, PhD, RN The Cleveland Clinic

Responsible Party: Nancy M. Albert PhD, RN, Cleveland Clinic Identifier: NCT00590369     History of Changes
Obsolete Identifiers: NCT00583141
Other Study ID Numbers: 8309-c
OSR 20050803
First Posted: January 10, 2008    Key Record Dates
Results First Posted: April 2, 2012
Last Update Posted: April 2, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Wounds and Injuries