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

NCT00994162 | Completed Results

• 1 other identifier: CIME 012
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds

Keywords

NPWT; Gauze-based filler; Acute or Chronic Wounds; Efficacy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Number of Participants Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Ease of Application and Removal Participant Questionnaire

  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

  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

  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

  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

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

Study Arms (1)

Negative Pressure Wound Therapy

EXPERIMENTAL

Application of NPWT therapy to the wound

Device: EZCare/V1STA Negative Pressure Wound Therapy System

Interventions

EZCare/V1STA Negative Pressure Wound Therapy System DEVICE

Vacuum Source and dressing kit that generates negative pressure over the wound.

Also known as: EZCare/V1STA Device and gauze-based filler dressing kit

Negative Pressure Wound Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (1)

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Related Publications (3)

• 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.

  PMID: 9188971 BACKGROUND

• 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.

  PMID: 12572233 BACKGROUND

• 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.

  PMID: 12579098 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Limitations and Caveats

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.

Results Point of Contact

• Title: Rachael Winter
• Organization: Smith+Nephew

rachael.winter@smith-nephew.com

+44 1482 673475

Study Officials

• Raymond M Dunn, MD

  UMass Memorial Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2009
• First Posted: October 14, 2009
• Study Start: April 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 21, 2022
• Results First Posted: September 21, 2022

Record last verified: 2020-03

Locations

US (1)