Evaluation of the Use of EZCare/V1STA in the Management of Acute and Chronic Wounds

Study Overview
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Brief Summary
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The aim of this evaluation is to assess the performance of the EZCare/V1STA products, 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.

Detailed Description
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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/V1STA products, 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. NOTE: While starting out as two individual studies (EZCare CIME 012 and V1STA CIME 010), these studies were ultimately combined and analyzed together as one set of results. The decision to report the two studies with a single Clinical Study Report was due to high levels of similarity in both the study designs and the products themselves; the individual study designs were largely similar with the same patient population criteria, study endpoints, and data capture requirements; and the products were identical in terms of their indications for use and therapeutic delivery of NPWT.

Official Title
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A Prospective, Open Labelled, Multicentre Evaluation of the Use of EZCare/V1STA in the Management of Acute and Chronic Wounds

Conditions
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Wounds

Intervention / Treatment
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* Device: EZCare/V1STA Negative Pressure Wound Therapy System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Negative Pressure Wound Therapy<br>Application of NPWT therapy to the wound | Device: EZCare/V1STA Negative Pressure Wound Therapy System<br>* Vacuum Source and dressing kit that generates negative pressure over the wound.<br>* Other names: EZCare/V1STA Device and gauze-based filler dressing kit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Wounds Stratified by Wound Area for the Performance of EZCare/V1STA in Terms of Wound Progress Towards Closure in Wounds Deemed Suitable for Treatment With Negative Pressure Wound Therapy (NPWT) - Wound Area (Baseline Measurements) | Evaluation was conducted to determine the extent of wound progression by the use of the NPWT EZCare/V1STA devices. Analysis of the amount of granulation tissue formation, successful management of exudate, and wound progression by reduction in area, volume, and depth were measured to assess improvement in wound healing. The wound was measured to assess wound area at Baseline. | Baseline | 
| Number of Wounds Stratified by Change in Wound Area for the Performance of EZCare/V1STA in Terms of Wound Progress Towards Closure in Wounds Deemed Suitable for Treatment With Negative Pressure Wound Therapy (NPWT) - Wound Area (Follow-up Visits) | Evaluation was conducted to determine the extent of wound progression by the use of the NPWT EZCare/V1STA devices. Analysis of wound progression by reduction in area was measured to assess improvement in wound healing. The wound was measured for change in wound area from Baseline compared to study discontinuation/withdrawal (up to 30 days of treatment plus a 7-day follow-up visit after discontinuation of NPWT). | Baseline to Treatment Discontinuation (up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation) | 
| Number of Wounds Stratified by Wound Volume for the Performance of EZCare/V1STA in Terms of Wound Progress Towards Closure in Wounds Deemed Suitable for Treatment With NPWT - Wound Volume (Baseline Measurements) | Evaluation was conducted to determine the extent of wound progression by the use of the NPWT EZCare/V1STA devices. Analysis of the amount of granulation tissue formation, successful management of exudate, and wound progression by reduction in area, volume, and depth were measured to assess improvement in wound healing. The wound was measured for wound volume at Baseline. | Baseline | 
| Number of Wounds Stratified by Change in Wound Volume for the Performance of EZCare/V1STA in Terms of Wound Progress Towards Closure in Wounds Deemed Suitable for Treatment With NPWT - Wound Volume (Follow-up Visits) | Evaluation was conducted to determine the extent of wound progression by the use of the NPWT EZCare/V1STA devices. Analysis of the amount of wound progression by reduction in volume was measured to assess improvement in wound healing. The wound was measured for change in wound volume from Baseline compared to study treatment discontinuation/withdrawal (up to 30 days of treatment plus a 7-day follow-up visit after discontinuation of NPWT). | Baseline to Treatment Discontinuation (up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation) | 
| Number of Wounds Stratified by Wound Depth for the Performance of EZCare/V1STA in Terms of Wound Progress Towards Closure in Wounds Deemed Suitable for Treatment With NPWT - Wound Depth (Baseline Measurements) | Evaluation was conducted to determine the extent of wound progression by the use of the NPWT EZCare/V1STA devices. Analysis of wound progression by reduction in depth was measured to assess improvement in wound healing. The wound was measured for wound depth at Baseline. | Baseline | 
| Number of Wounds Stratified by Improvement in Wound Depth for the Performance of EZCare/V1STA in Terms of Wound Progress Towards Closure in Wounds Deemed Suitable for Treatment With NPWT - Wound Depth (Follow-up Visits) | Evaluation was conducted to determine the extent of wound progression by the use of the NPWT EZCare/V1STA devices. Analysis of wound progression by improvement in depth was measured to assess improvement in wound healing. The wound was measured for change in depth from Baseline to study treatment discontinuation/withdrawal. | Baseline up to 20 weeks post initial treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Ease of Application and Removal Participant Questionnaire | Clinician evaluations of the general performance characteristics included ease of application and removal, duration of wear time, and time for each dressing change were assessed. The ease of application and removal of the dressing were assessed at study treatment discontinuation (removal)/study withdrawal. | Up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation | 
| Number of Wounds Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Duration of Wear Time | Evaluation of the general performance characteristics included ease of application and removal, duration of wear time, and time for each dressing change were assessed. Duration of wear time was assessed based on the Baseline level of exudate. | Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation | 
| Number of Dressing Changes Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Time for Each Dressing Change | Evaluation of the general performance characteristics included ease of application and removal, duration of wear time, and time for each dressing change were assessed. Based on the number of dressing changes performed throughout the study on all enrolled subjects, the average time it took to change each dressing was analyzed. | Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation | 
| Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Evaluation of wound pain was determined by assessing pain over the treatment period (unrelated to dressing application or removal). | Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation | 
| Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Evaluation of wound odor was assessed over the duration of the treatment period at each respective time point. | Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NPWT, Gauze-based filler, Acute or Chronic Wounds, Efficacy