Evaluation of the Use of EZCare◊ in the Management of Acute and Chronic Wounds (EZCARE-CIME)
|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|
- 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 ]
- 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 ]
|Study Start Date:||April 2008|
|Study Completion Date:||July 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994162
|United States, Massachusetts|
|UMass Memorial Medical Center|
|Worcester, Massachusetts, United States, 01655|
|Principal Investigator:||Raymond M Dunn, MD||UMass Memorial Medical Center|