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Negative Pressure Wound Therapy: Are All Systems Alike?

Primary Purpose

Wounds

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
KCI -VAC
Versatile One (EZCare)
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

KCI VAC type negative pressure wound therapy device

Versatile One (EZCare) negative wound therapy device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Cost of Wound Care
cost of device/supplies used in application and dressing changes
Nursing Time
Patient Reported Pain
scale of 0= no pain to 10= worst pain possible

Full Information

First Posted
December 26, 2007
Last Updated
March 30, 2012
Sponsor
The Cleveland Clinic
Collaborators
Smith & Nephew, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00590369
Brief Title
Negative Pressure Wound Therapy: Are All Systems Alike?
Official Title
Negative Pressure Wound Therapy: Are All Systems Alike?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Recruitment challenges
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Cleveland Clinic
Collaborators
Smith & Nephew, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
KCI VAC type negative pressure wound therapy device
Arm Title
2
Arm Type
Experimental
Arm Description
Versatile One (EZCare) negative wound therapy device
Intervention Type
Device
Intervention Name(s)
KCI -VAC
Intervention Description
Negative pressure wound therapy device
Intervention Type
Device
Intervention Name(s)
Versatile One (EZCare)
Intervention Description
Negative pressure wound therapy device
Primary Outcome Measure Information:
Title
5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling
Description
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
Secondary Outcome Measure Information:
Title
Ease of Performing Dressing Change
Description
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
Title
Ease of Providing Nursing Care
Description
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
Title
Cost of Wound Care
Description
cost of device/supplies used in application and dressing changes
Time Frame
during hospital stay; generally 6 days
Title
Nursing Time
Time Frame
hospital stay; generally 6 days
Title
Patient Reported Pain
Description
scale of 0= no pain to 10= worst pain possible
Time Frame
at first dressing change; generally 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy M Albert, PhD, RN
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44107
Country
United States

12. IPD Sharing Statement

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Negative Pressure Wound Therapy: Are All Systems Alike?

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