Negative Pressure Wound Therapy: Are All Systems Alike?

March 30, 2012 updated by: The Cleveland Clinic
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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

11

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44107
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
first dressing change; typically within 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during hospital stay; generally 6 days
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
during hospital stay; generally 6 days
Cost of Wound Care
Time Frame: during hospital stay; generally 6 days
cost of device/supplies used in application and dressing changes
during hospital stay; generally 6 days
Nursing Time
Time Frame: hospital stay; generally 6 days
hospital stay; generally 6 days
Patient Reported Pain
Time Frame: at first dressing change; generally 48 hours
scale of 0= no pain to 10= worst pain possible
at first dressing change; generally 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

Smith & Nephew, Inc.

Investigators

  • Principal Investigator: Nancy M Albert, PhD, RN, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

January 9, 2008

First Posted (Estimate)

January 10, 2008

Study Record Updates

Last Update Posted (Estimate)

April 2, 2012

Last Update Submitted That Met QC Criteria

March 30, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8309-c
  • OSR 20050803

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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