Negative Pressure Wound Therapy: Are All Systems Alike?

NCT ID: NCT00590369

Last Updated: 2012-04-02

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-08-31

Brief Summary

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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

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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

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Wounds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

KCI VAC type negative pressure wound therapy device

Group Type ACTIVE_COMPARATOR

KCI -VAC

Intervention Type DEVICE

Negative pressure wound therapy device

2

Versatile One (EZCare) negative wound therapy device

Group Type EXPERIMENTAL

Versatile One (EZCare)

Intervention Type DEVICE

Negative pressure wound therapy device

Interventions

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KCI -VAC

Negative pressure wound therapy device

Intervention Type DEVICE

Versatile One (EZCare)

Negative pressure wound therapy device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Smith & Nephew, Inc.

INDUSTRY

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Cleveland Clinic

Principal Investigators

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Nancy M Albert, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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OSR 20050803

Identifier Type: -

Identifier Source: secondary_id

8309-c

Identifier Type: -

Identifier Source: org_study_id

NCT00583141

Identifier Type: -

Identifier Source: nct_alias

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