N/A
Completed N=153
Evaluation of the Use of EZCare/V1STA in the Management of Acute and Chronic Wounds
Source: ClinicalTrials.gov NCT00994162 ↗Enrolled (actual)
153
Serious AEs
1.3%
Results posted
Sep 2022
Primary outcomePrimary: 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) — 36; 2; 28; 1 Wounds
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
36; 2; 28; 1; 63; 18 | — |
| PRIMARY 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) |
5; 1; 27; 1; 4; 0 | — |
| PRIMARY 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) |
42; 11; 51; 5; 30; 4 | — |
| PRIMARY 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) |
9; 3; 27; 8; 6; 0 | — |
| PRIMARY 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) |
4; 4; 99; 16; 19; 0 | — |
| PRIMARY 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) |
42.2; 70; 47.8; 38.8; 48.8; 29.1 | — |
| SECONDARY Number of Participants Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Ease of Application and Removal Participant Questionnaire |
64; 6; 56; 13; 3; 1 | — |
| SECONDARY Number of Wounds Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Duration of Wear Time |
2.8; 2.3; 2.9; 3.1; 2.7; 2.6 | — |
| SECONDARY Number of Dressing Changes Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Time for Each Dressing Change |
19.7; 14.2 | — |
| SECONDARY Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period |
58; 4; 42; 11; 24; 5 | — |
| SECONDARY Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period |
80; 18; 35; 3; 10; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00994162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.