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Evaluation of the Use of EZCare◊ in the Management of Acute and Chronic Wounds (EZCARE-CIME)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00994162
First Posted: October 14, 2009
Last Update Posted: September 10, 2012
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.
Information provided by (Responsible Party):
Smith & Nephew Wound Management Inc
  Purpose
The aim of this evaluation is to assess the performance of the EZCare◊ product, in many different clinical environments, in order to gain a greater insight into the effects of this negative pressure wound therapy (NPWT) in a variety of wound types.

Condition Intervention Phase
Wounds Device: EZCARE Negative Pressure Wound Therapy System Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open Labelled, Multicentre Evaluation of the Use of EZCare◊ in the Management of Acute and Chronic Wounds

Resource links provided by NLM:


Further study details as provided by Smith & Nephew Wound Management Inc:

Primary Outcome Measures:
  • The performance of EZCare◊ in terms of wound progress towards closure in wounds deemed suitable for treatment with negative pressure wound therapy [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • General performance characteristics. [ Time Frame: 12 months ]
  • Wound pain over the treatment period including pain upon application and removal of the dressing and therapy. [ Time Frame: 12 months ]
  • Wound odor over the treatment period. [ Time Frame: 12 months ]
  • All adverse events and product complaints throughout the evaluation. [ Time Frame: 12 months ]

Enrollment: 131
Study Start Date: April 2008
Study Completion Date: July 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Negative Pressure Wound Therapy
Application of NPWT therapy to the wound
Device: EZCARE Negative Pressure Wound Therapy System
Vacuum Source and dressing kit that generates negative pressure over the wound.
Other Name: EZCARE Device and gauze-based filler dressing kit

Detailed Description:

Patients meeting the eligibility criteria and agreeing to consent to their participation in the evaluation will receive treatment with the evaluation product for a maximum of 10 dressing changes or up to a maximum of 30 days treatment with the EZCare◊ product, whichever comes first. Treatment will commence on Day 0 and dressing changes will take place as deemed appropriate by the Clinician responsible for the patient, however it is recommended that the dressing is changed at least every 3 days in accordance with the product instructions for use.

Treatment will stop when, in the opinion of the Clinician, sufficient wound progress has taken place to merit a change in treatment regime i.e. surgical intervention (e.g. graft) or the use of more traditional dressings. Treatment with the evaluation product will not proceed past 30 days.

Patients will be treated with a pressure setting of between 40mmHg and 80mmHg for the duration of treatment.

A follow up wound assessment will take place 7 days post treatment discontinuation.

If required, debridement may be performed prior to and during the patients participation in this evaluation.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must be at least 18 years of age
  • Males and females - provided they are not pregnant and if of reproductive age are using contraception
  • The patient must have an acute or chronic wound deemed suitable for treatment with NPWT
  • The patient is able to understand the evaluation and is willing to consent to the evaluation

Exclusion Criteria:

  • Presence of necrotic tissue or >25% slough in the reference wound. Once debridement has taken place the patient may proceed to enter the evaluation.
  • Previously confirmed and untreated osteomyelitis.
  • Malignancy in the reference wound bed or margins of the wound.
  • Active bleeding in the reference wound. Once haemostasis has been achieved, the patient may proceed to enter the evaluation.
  • Exposure of blood vessels or organs at the base of the reference wound.
  • Presence of untreated infection in the reference wound. (Infected wounds being treated with systemic antibiotics are permitted)
  • Patients with a known history of poor compliance with medical treatment.
  • Patients who have participated in this evaluation previously and who healed or were withdrawn
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00994162


Locations
United States, Massachusetts
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
Smith & Nephew Wound Management Inc
Investigators
Principal Investigator: Raymond M Dunn, MD UMass Memorial Medical Center
  More Information

Publications:
Responsible Party: Smith & Nephew Wound Management Inc
ClinicalTrials.gov Identifier: NCT00994162     History of Changes
Other Study ID Numbers: CIME 012
First Submitted: October 9, 2009
First Posted: October 14, 2009
Last Update Posted: September 10, 2012
Last Verified: September 2012

Keywords provided by Smith & Nephew Wound Management Inc:
NPWT
Gauze-based filler
Acute or Chronic Wounds
Efficacy

Additional relevant MeSH terms:
Wounds and Injuries