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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:
Information provided by (Responsible Party):
Smith & Nephew Wound Management Inc
ClinicalTrials.gov Identifier:
NCT00994162
First received: October 9, 2009
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 9, 2009
Last Updated: September 7, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013