Negative Pressure Wound Therapy: Are All Systems Alike?

This study has been terminated.
(Recruitment challenges)
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00590369
First received: December 26, 2007
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Wounds
Device: KCI -VAC
Device: Versatile One (EZCare)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Negative Pressure Wound Therapy: Are All Systems Alike?

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling [ Time Frame: first dressing change; typically within 48 hours ] [ Designated as safety issue: No ]
    differences in wound healing rate at first dressing between devices; since 5 variables were assessed via a centimeter ruler


Secondary Outcome Measures:
  • Ease of Performing Dressing Change [ Time Frame: during hospital stay; generally 6 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: during hospital stay; generally 6 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: during hospital stay; generally 6 days ] [ Designated as safety issue: No ]
    cost of device/supplies used in application and dressing changes

  • Nursing Time [ Time Frame: hospital stay; generally 6 days ] [ Designated as safety issue: No ]
  • Patient Reported Pain [ Time Frame: at first dressing change; generally 48 hours ] [ Designated as safety issue: No ]
    scale of 0= no pain to 10= worst pain possible


Enrollment: 11
Study Start Date: January 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590369

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

No publications provided

Responsible Party: Nancy M. Albert PhD, RN, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00590369     History of Changes
Obsolete Identifiers: NCT00583141
Other Study ID Numbers: 8309-c, OSR 20050803
Study First Received: December 26, 2007
Results First Received: June 22, 2011
Last Updated: March 30, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 29, 2014