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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.
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.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
EZCARE Negative Pressure Wound Therapy System
UMass Memorial Medical Center
Smith & Nephew Wound Management Inc
Published on BioPortfolio: 2014-07-23T21:12:29-0400
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