WoundsEZCARE/V1STANCT00994162

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

A study testing EZCare/V1STA Negative Pressure Wound Therapy System in people with Wounds, run by Smith & Nephew, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Wounds
What is being tested?: EZCare/V1STA Negative Pressure Wound Therapy System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 153 participants
Where: 1 siteUnited States
Study dates: Apr 2008to Jul 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UMass Memorial Medical Center
Worcester, Massachusetts, 01655

Other trials in United States

About this study

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

Read the 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.

Conditions: Wounds
Being tested: EZCare/V1STA Negative Pressure Wound Therapy System
Keywords: NPWT, Gauze-based filler, Acute or Chronic Wounds, Efficacy
Medical subject headings: Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EZCare/V1STA Negative Pressure Wound Therapy SystemDevice
Also called EZCare/V1STA Device and gauze-based filler dressing kit
Vacuum Source and dressing kit that generates negative pressure over the wound.

Study groups in NCT00994162
Study group	Role	What they receive
Negative Pressure Wound Therapy	Experimental	Application of NPWT therapy to the wound Receives: Device: EZCare/V1STA Negative Pressure Wound Therapy System

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline up to 20 weeks post initial treatment

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Jul 2009

First posted14 Oct 2009 (estimated)
Study startApr 2008
Primary completionJan 2009
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for WoundsStudies of the same condition, open and under way.
More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00994162
Sponsor's protocol ID: CIME 012
Acronym: EZCARE/V1STA
Status last verified: Mar 2020
First submitted: 9 Oct 2009
Last updated: 21 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 9188971
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.
PubMed 12572233
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.
PubMed 12579098

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Wounds trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Open Labelled, Multicentre Evaluation of the Use of EZCare/V1STA in the Management of Acute and Chronic Wounds
ClinicalTrials.gov ID: NCT00994162
Acronym / sponsor ID: EZCARE/V1STA / CIME 012
Conditions: Wounds
Keywords: NPWT, Gauze-based filler, Acute or Chronic Wounds, Efficacy
Study type: Interventional
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Jan 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 14 Oct 2009 (estimated)
Results: Posted 21 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Negative Pressure Wound Therapy	Experimental	Device: EZCare/V1STA Negative Pressure Wound Therapy SystemApplication of NPWT therapy to the wound

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EZCare/V1STA Negative Pressure Wound Therapy SystemAlso: EZCare/V1STA Device and gauze-based filler dressing kitVacuum Source and dressing kit that generates negative pressure over the wound.	Device	Negative Pressure Wound Therapy

Primary outcome

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)
Time frame: Baseline
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.
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)
Time frame: Baseline to Treatment Discontinuation (up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation)
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).
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)
Time frame: Baseline
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.
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)
Time frame: Baseline to Treatment Discontinuation (up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation)
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).
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)
Time frame: Baseline
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.
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)
Time frame: Baseline up to 20 weeks post initial treatment
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.

5 secondary outcomes

Number of Participants Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Ease of Application and Removal Participant Questionnaire
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation

Results and safety

Results posted to the registry on 21 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Negative Pressure Wound Therapy	153	125

Primary outcome: 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)

Time frame: Baseline. Count of units. Unit: Wounds

Measure	NPWT (Non-Grafted Sites) n = 127	NPWT (Grafted Sites) n = 21
<10 cm^2 wound area	36	2
10 cm^2 to <20 cm^2 wound area	28	1
>= 20 cm^2 wound area	63	18

Population analysed: The study was further divided into subgroups of subjects with a grafted wound site or subjects with a non-grafted wound site to compare wound types. The data presented represent the enrolled subjects present at Baseline as provided by the site.

Primary outcome: 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)

Time frame: Baseline to Treatment Discontinuation (up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation). Count of units. Unit: Wounds

Measure	NPWT (Non-Grafted Sites) n = 125	NPWT (Grafted Sites) n = 21
Wound Progression at Treatment Discontinuation by Baseline Wound Area <10 cm^2: Healed/Closed	5	1
Wound Progression at Treatment Discontinuation by Baseline Wound Area <10 cm^2: Progressing to closure/healing	27	1
Wound Progression at Treatment Discontinuation by Baseline Wound Area <10 cm^2: Not progressing to closure/healing	4	0
Wound Progression at Treatment Discontinuation by Baseline Wound Area 10 cm^2 to <20 cm^2: Healed/Closed	7	1
Wound Progression at Treatment Discontinuation by Baseline Wound Area 10 cm^2 to <20 cm^2: Progressing to closure/healing	18	0
Wound Progression at Treatment Discontinuation by Baseline Wound Area 10 cm^2 to <20 cm^2: Not progressing to closure/healing	2	0
Wound Progression at Treatment Discontinuation by Baseline Wound Area >= 20 cm^2: Healed/Closed	4	4
Wound Progression at Treatment Discontinuation by Baseline Wound Area >= 20 cm^2: Progressing to closure/healing	51	13

Primary outcome: 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)

Time frame: Baseline. Count of units. Unit: Wounds

Measure	NPWT (Non-Grafted Sites) n = 123	NPWT (Grafted Sites) n = 20
<20 cm^3 wound volume	42	11
20 cm^3 to <100 cm^3 wound volume	51	5
>= 100 cm^3 wound volume	30	4

Primary outcome: 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)

Time frame: Baseline to Treatment Discontinuation (up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation). Count of units. Unit: Wounds

Measure	NPWT (Non-Grafted Sites) n = 123	NPWT (Grafted Sites) n = 20
Wound Progression at Treatment Discontinuation by Baseline Wound Volume <20 cm^3: Healed/closed	9	3
Wound Progression at Treatment Discontinuation by Baseline Wound Volume <20 cm^3: Progressing to closure/healing	27	8
Wound Progression at Treatment Discontinuation by Baseline Wound Volume <20 cm^3: Not progressing to closure/healing	6	0
Wound Progression at Treatment Discontinuation by Baseline Wound Volume 20 cm^3 to <100 cm^3: Healed/closed	5	1
Wound Progression at Treatment Discontinuation by Baseline Wound Volume 20 cm^3 to <100 cm^3: Progressing to closure/healing	41	3
Wound Progression at Treatment Discontinuation by Baseline Wound Volume 20 cm^3 to <100 cm^3: Not progressing to closure/healing	5	1
Wound Progression at Treatment Discontinuation by Baseline Wound Volume >= 100 cm^3: Healed/closed	2	1
Wound Progression at Treatment Discontinuation by Baseline Wound Volume >= 100 cm^3: Progressing to closure/healing	26	3

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through end of study treatment (30 days of treatment plus 7-day follow-up assessment).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Negative Pressure Wound Therapy	2 of 153 (1.3%)	1 of 153 (0.7%)	2 of 153

Limitations and caveats (from the sponsor): While starting out as two individual studies (EZCare CIME 012 and V1STA CIME 010), these studies were combined and analyzed together as one set of results due to high levels of similarity in both the study designs and the products themselves. This was a non-controlled study delivering a global dataset with potential bias towards North America. V1STA was set up as a global study and EZCare was focused on the USA and Canada. This resulted in 108 of the 153 patients being from North America.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 9188971Argenta 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.
Background: PubMed 12572233Banwell 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.
Background: PubMed 12579098Luckraz 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Raymond M Dunn, MD principal investigator

UMass Memorial Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EZCare/V1STA Negative Pressure Wound Therapy System in people with Wounds, run by Smith & Nephew, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00994162, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.