Clinical trial NCT00994162: Evaluation of the Use of EZCare/V1STA in the Management of Acute and Chronic Wounds
Official title: A Prospective, Open Labelled, Multicentre Evaluation of the Use of EZCare/V1STA in the Management of Acute and Chronic Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds
Keywords: NPWT
Gauze-based filler
Acute or Chronic Wounds
Efficacy
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-14
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: Baseline
measure: 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)
timeFrame: Baseline to Treatment Discontinuation (up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation)
measure: 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)
timeFrame: Baseline
measure: 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)
timeFrame: Baseline to Treatment Discontinuation (up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation)
measure: 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)
timeFrame: Baseline
measure: 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)
timeFrame: Baseline up to 20 weeks post initial treatment
Secondary outcomes:
measure: Number of Participants Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Ease of Application and Removal Participant Questionnaire
timeFrame: Up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation
measure: Number of Wounds Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Duration of Wear Time
timeFrame: Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation
measure: Number of Dressing Changes Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Time for Each Dressing Change
timeFrame: Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation
measure: Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period
timeFrame: Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation
measure: Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period
timeFrame: Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: UMass Memorial Health
name: Raymond M Dunn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Argenta LC, Morykwas MJ. Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg. 1997 Jun;38(6):563-76; discussion 577.
citation: Banwell PE, Teot L. Topical negative pressure (TNP): the evolution of a novel wound therapy. J Wound Care. 2003 Jan;12(1):22-8. doi: 10.12968/jowc.2003.12.1.26451.
citation: Luckraz H, Murphy F, Bryant S, Charman SC, Ritchie AJ. Vacuum-assisted closure as a treatment modality for infections after cardiac surgery. J Thorac Cardiovasc Surg. 2003 Feb;125(2):301-5. doi: 10.1067/mtc.2003.74.