Wounds
Conditions
Keywords
NPWT, Gauze-based filler, Acute or Chronic Wounds, Efficacy
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.
Interventions
DEVICEEZCare/V1STA Negative Pressure Wound Therapy System
Vacuum Source and dressing kit that generates negative pressure over the wound.
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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) | 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) | 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) | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| 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 | Evaluation of wound pain was determined by assessing pain over the treatment period (unrelated to dressing application or removal). |
| 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 | Evaluation of wound odor was assessed over the duration of the treatment period at each respective time point. |
| 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 | 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. |
Countries
United States
Participant flow
Recruitment details
While starting out as 2 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 2 studies with a single CSR was due to high levels of similarity in both the study designs and the products themselves. The study was further divided into subgroups of subjects with a grafted wound site (21 subjects) or subjects with a non-grafted wound site (131 subjects) to compare wound types.
Pre-assignment details
A total of 153 subjects were enrolled; however, one V1STA subject was withdrawn from the study due to medical complications that prohibited the application of the NPWT system. The subject was excluded from the full analysis set (FAS) population, but included in the safety (SAF) population.
Participants by arm
| Arm | Count |
|---|---|
| NPWT (Non-Grafted Sites) Application of NPWT therapy to the wound - subjects with a non-grafted wound site
EZCARE/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound. | 131 |
| NPWT (Grafted Sites) Application of NPWT therapy to the wound - subjects with a grafted wound site
EZCARE/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound. | 21 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Above Knee Amputation | 1 |
| Overall Study | Care Transferred to Another Physician | 2 |
| Overall Study | Death | 2 |
| Overall Study | Discharged from Hospital | 4 |
| Overall Study | Discontinued and Changed to Iodoflex | 1 |
| Overall Study | Lack of Response | 3 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Machine Losing Vaccum | 1 |
| Overall Study | Patient Lived Too Far Away | 1 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Poor Compliance | 5 |
| Overall Study | Product Complaint | 1 |
| Overall Study | Reason Not Reported By Site | 1 |
| Overall Study | Surrounding Wound Erythematous | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | NPWT (Grafted Sites) | NPWT (Non-Grafted Sites) | Total |
|---|---|---|---|
| Age, Continuous | 43.2 years of age STANDARD_DEVIATION 16.2 | 60.5 years of age STANDARD_DEVIATION 16.8 | 58.0 years of age STANDARD_DEVIATION 17.8 |
| Medical History Anemia Current condition | 0 Participants | 8 Participants | 8 Participants |
| Medical History Anemia Had condition, current/prior not given | 1 Participants | 4 Participants | 5 Participants |
| Medical History Anemia Never had the condition | 20 Participants | 116 Participants | 136 Participants |
| Medical History Anemia Prior condition | 0 Participants | 3 Participants | 3 Participants |
| Medical History Congestive heart failure Current condition | 0 Participants | 4 Participants | 4 Participants |
| Medical History Congestive heart failure Had condition, current/prior not given | 0 Participants | 6 Participants | 6 Participants |
| Medical History Congestive heart failure Never had the condition | 20 Participants | 119 Participants | 139 Participants |
| Medical History Congestive heart failure Prior condition | 1 Participants | 2 Participants | 3 Participants |
| Medical History Deep vein thrombosis (DVT) Current condition | 0 Participants | 1 Participants | 1 Participants |
| Medical History Deep vein thrombosis (DVT) Had condition, current/prior not given | 0 Participants | 0 Participants | 0 Participants |
| Medical History Deep vein thrombosis (DVT) Never had the condition | 21 Participants | 129 Participants | 150 Participants |
| Medical History Deep vein thrombosis (DVT) Prior condition | 0 Participants | 1 Participants | 1 Participants |
| Medical History Diabetes Current condition | 4 Participants | 26 Participants | 30 Participants |
| Medical History Diabetes Had condition, current/prior not given | 1 Participants | 23 Participants | 24 Participants |
| Medical History Diabetes Never had the condition | 16 Participants | 80 Participants | 96 Participants |
| Medical History Diabetes Prior condition | 0 Participants | 2 Participants | 2 Participants |
| Medical History Hypertension Current condition | 2 Participants | 29 Participants | 31 Participants |
| Medical History Hypertension Had condition, current/prior not given | 1 Participants | 27 Participants | 28 Participants |
| Medical History Hypertension Never had the condition | 18 Participants | 73 Participants | 91 Participants |
| Medical History Hypertension Prior condition | 0 Participants | 2 Participants | 2 Participants |
| Medical History Osteoarthritis Current condition | 0 Participants | 3 Participants | 3 Participants |
| Medical History Osteoarthritis Had condition, current/prior not given | 0 Participants | 16 Participants | 16 Participants |
| Medical History Osteoarthritis Never had the condition | 21 Participants | 112 Participants | 133 Participants |
| Medical History Osteoarthritis Prior condition | 0 Participants | 0 Participants | 0 Participants |
| Medical History Peripheral vascular disease Current condition | 0 Participants | 11 Participants | 11 Participants |
| Medical History Peripheral vascular disease Had condition, current/prior not given | 1 Participants | 17 Participants | 18 Participants |
| Medical History Peripheral vascular disease Never had the condition | 20 Participants | 102 Participants | 122 Participants |
| Medical History Peripheral vascular disease Prior condition | 0 Participants | 1 Participants | 1 Participants |
| Medical History Rheumatoid arthritis Current condition | 0 Participants | 2 Participants | 2 Participants |
| Medical History Rheumatoid arthritis Had condition, current/prior not given | 0 Participants | 5 Participants | 5 Participants |
| Medical History Rheumatoid arthritis Never had the condition | 21 Participants | 124 Participants | 145 Participants |
| Medical History Rheumatoid arthritis Prior condition | 0 Participants | 0 Participants | 0 Participants |
| Medical History Stroke/cardiovascular accident (CVA) Current condition | 0 Participants | 3 Participants | 3 Participants |
| Medical History Stroke/cardiovascular accident (CVA) Had condition, current/prior not given | 0 Participants | 7 Participants | 7 Participants |
| Medical History Stroke/cardiovascular accident (CVA) Never had the condition | 21 Participants | 114 Participants | 135 Participants |
| Medical History Stroke/cardiovascular accident (CVA) Prior condition | 0 Participants | 7 Participants | 7 Participants |
| Medical History Varicose veins Current condition | 0 Participants | 2 Participants | 2 Participants |
| Medical History Varicose veins Had condition, current/prior not given | 1 Participants | 2 Participants | 3 Participants |
| Medical History Varicose veins Never had the condition | 20 Participants | 126 Participants | 146 Participants |
| Medical History Varicose veins Prior condition | 0 Participants | 1 Participants | 1 Participants |
| Patient Mobility Bed Bound | 1 Participants | 31 Participants | 32 Participants |
| Patient Mobility Chair Bound | 2 Participants | 16 Participants | 18 Participants |
| Patient Mobility Chair Bound/Bed Bound | 0 Participants | 3 Participants | 3 Participants |
| Patient Mobility Walks Unaided | 12 Participants | 50 Participants | 62 Participants |
| Patient Mobility Walks Unaided/Walks with Aid | 1 Participants | 0 Participants | 1 Participants |
| Patient Mobility Walks with Aid | 5 Participants | 30 Participants | 35 Participants |
| Patient Mobility Walks with Aid/Chair Bound | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 5 Participants | 61 Participants | 66 Participants |
| Sex: Female, Male Male | 16 Participants | 69 Participants | 85 Participants |
| Treatment Setting Home | 2 Participants | 29 Participants | 31 Participants |
| Treatment Setting Hospital | 19 Participants | 76 Participants | 95 Participants |
| Treatment Setting Long-term care/nursing home | 0 Participants | 3 Participants | 3 Participants |
| Treatment Setting Wound Clinic | 0 Participants | 23 Participants | 23 Participants |
| Wound Type Diabetic foot ulcer | 0 Participants | 15 Participants | 15 Participants |
| Wound Type Graft site | 21 Participants | 0 Participants | 21 Participants |
| Wound Type Leg ulcer | 0 Participants | 4 Participants | 4 Participants |
| Wound Type Other wound | 0 Participants | 3 Participants | 3 Participants |
| Wound Type Pressure ulcer | 0 Participants | 34 Participants | 34 Participants |
| Wound Type Surgical wound | 0 Participants | 63 Participants | 63 Participants |
| Wound Type Traumatic wound | 0 Participants | 12 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 153 |
| other Total, other adverse events | 1 / 153 |
| serious Total, serious adverse events | 2 / 153 |
Outcome results
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)
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).
Time frame: Baseline to Treatment Discontinuation (up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation)
Population: 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 showing measurable reduction in wound area from Baseline measurements at the specified time point visits.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| NPWT (Non-Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Area <10 cm^2 | Progressing to closure/healing | 27 Wounds |
| NPWT (Non-Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Area 10 cm^2 to <20 cm^2 | Not progressing to closure/healing | 2 Wounds |
| NPWT (Non-Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Area 10 cm^2 to <20 cm^2 | Healed/Closed | 7 Wounds |
| NPWT (Non-Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Area >= 20 cm^2 | Healed/Closed | 4 Wounds |
| NPWT (Non-Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Area <10 cm^2 | Not progressing to closure/healing | 4 Wounds |
| NPWT (Non-Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Area >= 20 cm^2 | Progressing to closure/healing | 51 Wounds |
| NPWT (Non-Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Area 10 cm^2 to <20 cm^2 | Progressing to closure/healing | 18 Wounds |
| NPWT (Non-Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Area >= 20 cm^2 | Not progressing to closure/healing | 7 Wounds |
| NPWT (Non-Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Area <10 cm^2 | Healed/Closed | 5 Wounds |
| NPWT (Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Area >= 20 cm^2 | Not progressing to closure/healing | 1 Wounds |
| NPWT (Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Area <10 cm^2 | Healed/Closed | 1 Wounds |
| NPWT (Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Area <10 cm^2 | Progressing to closure/healing | 1 Wounds |
| NPWT (Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Area <10 cm^2 | Not progressing to closure/healing | 0 Wounds |
| NPWT (Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Area 10 cm^2 to <20 cm^2 | Healed/Closed | 1 Wounds |
| NPWT (Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Area 10 cm^2 to <20 cm^2 | Progressing to closure/healing | 0 Wounds |
| NPWT (Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Area 10 cm^2 to <20 cm^2 | Not progressing to closure/healing | 0 Wounds |
| NPWT (Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Area >= 20 cm^2 | Healed/Closed | 4 Wounds |
| NPWT (Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Area >= 20 cm^2 | Progressing to closure/healing | 13 Wounds |
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)
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).
Time frame: Baseline to Treatment Discontinuation (up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation)
Population: 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 showing measurable reduction in wound volume from Baseline measurements at the specified time point visits.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| NPWT (Non-Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Volume <20 cm^3 | Progressing to closure/healing | 27 Wounds |
| NPWT (Non-Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Volume 20 cm^3 to <100 cm^3 | Not progressing to closure/healing | 5 Wounds |
| NPWT (Non-Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Volume 20 cm^3 to <100 cm^3 | Healed/closed | 5 Wounds |
| NPWT (Non-Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Volume >= 100 cm^3 | Healed/closed | 2 Wounds |
| NPWT (Non-Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Volume <20 cm^3 | Not progressing to closure/healing | 6 Wounds |
| NPWT (Non-Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Volume >= 100 cm^3 | Progressing to closure/healing | 26 Wounds |
| NPWT (Non-Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Volume 20 cm^3 to <100 cm^3 | Progressing to closure/healing | 41 Wounds |
| NPWT (Non-Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Volume >= 100 cm^3 | Not progressing to closure/healing | 2 Wounds |
| NPWT (Non-Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Volume <20 cm^3 | Healed/closed | 9 Wounds |
| NPWT (Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Volume >= 100 cm^3 | Not progressing to closure/healing | 0 Wounds |
| NPWT (Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Volume <20 cm^3 | Healed/closed | 3 Wounds |
| NPWT (Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Volume <20 cm^3 | Progressing to closure/healing | 8 Wounds |
| NPWT (Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Volume <20 cm^3 | Not progressing to closure/healing | 0 Wounds |
| NPWT (Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Volume 20 cm^3 to <100 cm^3 | Healed/closed | 1 Wounds |
| NPWT (Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Volume 20 cm^3 to <100 cm^3 | Progressing to closure/healing | 3 Wounds |
| NPWT (Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Volume 20 cm^3 to <100 cm^3 | Not progressing to closure/healing | 1 Wounds |
| NPWT (Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Volume >= 100 cm^3 | Healed/closed | 1 Wounds |
| NPWT (Grafted Sites) | 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) | Wound Progression at Treatment Discontinuation by Baseline Wound Volume >= 100 cm^3 | Progressing to closure/healing | 3 Wounds |
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)
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.
Time frame: Baseline up to 20 weeks post initial treatment
Population: 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 showing measurable improvement in wound depth from Baseline measurements at the specified time point visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NPWT (Non-Grafted Sites) | 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) | Wound Duration <1 Week | 42.2 percentage of improvement in depth | Standard Deviation 23.4 |
| NPWT (Non-Grafted Sites) | 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) | Wound Duration 1 - <4 Weeks | 47.8 percentage of improvement in depth | Standard Deviation 68.1 |
| NPWT (Non-Grafted Sites) | 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) | Wound Duration 4 - <20 Weeks | 48.8 percentage of improvement in depth | Standard Deviation 33.9 |
| NPWT (Non-Grafted Sites) | 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) | Wound Duration >=20 Weeks | 41.0 percentage of improvement in depth | Standard Deviation 49.7 |
| NPWT (Grafted Sites) | 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) | Wound Duration >=20 Weeks | 29.1 percentage of improvement in depth | Standard Deviation 15.4 |
| NPWT (Grafted Sites) | 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) | Wound Duration <1 Week | 70 percentage of improvement in depth | Standard Deviation 42.4 |
| NPWT (Grafted Sites) | 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) | Wound Duration 4 - <20 Weeks | 29.1 percentage of improvement in depth | Standard Deviation 15.4 |
| NPWT (Grafted Sites) | 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) | Wound Duration 1 - <4 Weeks | 38.8 percentage of improvement in depth | Standard Deviation 46.9 |
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)
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| NPWT (Non-Grafted Sites) | 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) | <10 cm^2 wound area | 36 Wounds |
| NPWT (Non-Grafted Sites) | 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) | 10 cm^2 to <20 cm^2 wound area | 28 Wounds |
| NPWT (Non-Grafted Sites) | 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) | >= 20 cm^2 wound area | 63 Wounds |
| NPWT (Grafted Sites) | 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) | <10 cm^2 wound area | 2 Wounds |
| NPWT (Grafted Sites) | 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) | 10 cm^2 to <20 cm^2 wound area | 1 Wounds |
| NPWT (Grafted Sites) | 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) | >= 20 cm^2 wound area | 18 Wounds |
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)
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.
Time frame: Baseline
Population: 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 at Baseline.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| NPWT (Non-Grafted Sites) | 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) | 0 cm wound depth | 4 Wounds |
| NPWT (Non-Grafted Sites) | 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 cm to <8 cm wound depth | 19 Wounds |
| NPWT (Non-Grafted Sites) | 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) | >0 cm to <4 cm wound depth | 99 Wounds |
| NPWT (Non-Grafted Sites) | 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) | >= 8 cm wound depth | 4 Wounds |
| NPWT (Grafted Sites) | 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) | >= 8 cm wound depth | 0 Wounds |
| NPWT (Grafted Sites) | 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) | 0 cm wound depth | 4 Wounds |
| NPWT (Grafted Sites) | 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) | >0 cm to <4 cm wound depth | 16 Wounds |
| NPWT (Grafted Sites) | 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 cm to <8 cm wound depth | 0 Wounds |
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)
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| NPWT (Non-Grafted Sites) | 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) | <20 cm^3 wound volume | 42 Wounds |
| NPWT (Non-Grafted Sites) | 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) | 20 cm^3 to <100 cm^3 wound volume | 51 Wounds |
| NPWT (Non-Grafted Sites) | 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) | >= 100 cm^3 wound volume | 30 Wounds |
| NPWT (Grafted Sites) | 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) | >= 100 cm^3 wound volume | 4 Wounds |
| NPWT (Grafted Sites) | 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) | <20 cm^3 wound volume | 11 Wounds |
| NPWT (Grafted Sites) | 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) | 20 cm^3 to <100 cm^3 wound volume | 5 Wounds |
Secondary
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.
Time frame: Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation
Population: 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 how many minutes on average it took to change the dressing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NPWT (Non-Grafted Sites) | Number of Dressing Changes Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Time for Each Dressing Change | 19.7 minutes | Standard Deviation 10.4 |
| NPWT (Grafted Sites) | Number of Dressing Changes Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Time for Each Dressing Change | 14.2 minutes | Standard Deviation 8.4 |
Secondary
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.
Time frame: Up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation
Population: 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 represents the clinician assessments for all enrolled subjects at the time of satisfaction survey.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| NPWT (Non-Grafted Sites) | Number of Participants Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Ease of Application and Removal Participant Questionnaire | Ease of Removal of Dressing | Exceeds expectations | 65 Participants |
| NPWT (Non-Grafted Sites) | Number of Participants Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Ease of Application and Removal Participant Questionnaire | Ease of Application of Dressing | Satisfied | 56 Participants |
| NPWT (Non-Grafted Sites) | Number of Participants Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Ease of Application and Removal Participant Questionnaire | Ease of Removal of Dressing | Satisfied | 58 Participants |
| NPWT (Non-Grafted Sites) | Number of Participants Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Ease of Application and Removal Participant Questionnaire | Ease of Application of Dressing | Dissatisfied | 3 Participants |
| NPWT (Non-Grafted Sites) | Number of Participants Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Ease of Application and Removal Participant Questionnaire | Ease of Removal of Dressing | Dissatisfied | 0 Participants |
| NPWT (Non-Grafted Sites) | Number of Participants Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Ease of Application and Removal Participant Questionnaire | Ease of Application of Dressing | Exceeds expectations | 64 Participants |
| NPWT (Grafted Sites) | Number of Participants Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Ease of Application and Removal Participant Questionnaire | Ease of Removal of Dressing | Dissatisfied | 0 Participants |
| NPWT (Grafted Sites) | Number of Participants Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Ease of Application and Removal Participant Questionnaire | Ease of Application of Dressing | Exceeds expectations | 6 Participants |
| NPWT (Grafted Sites) | Number of Participants Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Ease of Application and Removal Participant Questionnaire | Ease of Application of Dressing | Dissatisfied | 1 Participants |
| NPWT (Grafted Sites) | Number of Participants Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Ease of Application and Removal Participant Questionnaire | Ease of Removal of Dressing | Exceeds expectations | 6 Participants |
| NPWT (Grafted Sites) | Number of Participants Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Ease of Application and Removal Participant Questionnaire | Ease of Removal of Dressing | Satisfied | 14 Participants |
| NPWT (Grafted Sites) | Number of Participants Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Ease of Application and Removal Participant Questionnaire | Ease of Application of Dressing | Satisfied | 13 Participants |
Secondary
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.
Time frame: Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation
Population: 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 necessitating dressing changes based on level of exudate from wound at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Duration of Wear Time | Baseline Level of Exudate - Mild (duration of wear time) | 2.9 days | Standard Deviation 0.5 |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Duration of Wear Time | Baseline Level of Exudate - Heavy (duration of wear time) | 2.7 days | Standard Deviation 0.7 |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Duration of Wear Time | Overall Duration of Wear Time by Level of Exudate | 2.8 days | Standard Deviation 0.5 |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Duration of Wear Time | Baseline Level of Exudate - None (duration of wear time) | 2.8 days | Standard Deviation 0.5 |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Duration of Wear Time | Baseline Level of Exudate - Moderate (duration of wear time) | 2.7 days | Standard Deviation 0.5 |
| NPWT (Grafted Sites) | Number of Wounds Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Duration of Wear Time | Overall Duration of Wear Time by Level of Exudate | 2.8 days | Standard Deviation 1.3 |
| NPWT (Grafted Sites) | Number of Wounds Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Duration of Wear Time | Baseline Level of Exudate - Mild (duration of wear time) | 3.1 days | Standard Deviation 1.2 |
| NPWT (Grafted Sites) | Number of Wounds Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Duration of Wear Time | Baseline Level of Exudate - Moderate (duration of wear time) | 2.6 days | Standard Deviation 0.9 |
| NPWT (Grafted Sites) | Number of Wounds Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Duration of Wear Time | Baseline Level of Exudate - None (duration of wear time) | 2.3 days | Standard Deviation 2.1 |
Secondary
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.
Time frame: Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation
Population: 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 participating in the survey at each specified time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at Baseline | None | 80 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at Baseline | Slight | 35 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at Baseline | Moderate | 10 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at Baseline | Strong | 6 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at Treatment Discontinuation | None | 107 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at Treatment Discontinuation | Slight | 19 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at Treatment Discontinuation | Moderate | 2 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at Treatment Discontinuation | Strong | 2 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at 7-Day Post Treatment Follow-up Visit | None | 59 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at 7-Day Post Treatment Follow-up Visit | Slight | 5 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at 7-Day Post Treatment Follow-up Visit | Moderate | 2 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at 7-Day Post Treatment Follow-up Visit | Strong | 0 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at 7-Day Post Treatment Follow-up Visit | Moderate | 0 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at Baseline | None | 18 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at Treatment Discontinuation | Moderate | 0 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at Baseline | Slight | 3 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at 7-Day Post Treatment Follow-up Visit | Slight | 1 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at Baseline | Moderate | 0 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at Treatment Discontinuation | Strong | 0 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at Baseline | Strong | 0 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at 7-Day Post Treatment Follow-up Visit | Strong | 0 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at Treatment Discontinuation | None | 19 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at 7-Day Post Treatment Follow-up Visit | None | 15 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Level of Wound Odor at Treatment Discontinuation | Slight | 1 Wounds |
Secondary
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).
Time frame: Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation
Population: 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' survey responses at each time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain at Dressing Removal Overall | Mild | 108 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at Baseline | None | 58 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at Baseline | Mild | 42 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at Baseline | Moderate | 24 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at Baseline | Severe | 6 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at Treatment Discontinuation | None | 101 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at Treatment Discontinuation | Mild | 23 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at Treatment Discontinuation | Moderate | 6 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at Treatment Discontinuation | Severe | 0 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at 7-Day Post Treatment Follow-up Visit | None | 63 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at 7-Day Post Treatment Follow-up Visit | Mild | 7 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at 7-Day Post Treatment Follow-up Visit | Moderate | 3 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at 7-Day Post Treatment Follow-up Visit | Severe | 0 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain at Dressing Removal Overall | None | 666 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain at Dressing Removal Overall | Moderate | 37 Wounds |
| NPWT (Non-Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain at Dressing Removal Overall | Severe | 2 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain at Dressing Removal Overall | Severe | 1 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain at Dressing Removal Overall | Mild | 17 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at Treatment Discontinuation | Severe | 0 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at Baseline | None | 4 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at 7-Day Post Treatment Follow-up Visit | Severe | 0 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at Baseline | Mild | 11 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at 7-Day Post Treatment Follow-up Visit | None | 11 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at Baseline | Moderate | 5 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain at Dressing Removal Overall | Moderate | 1 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at Baseline | Severe | 1 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at 7-Day Post Treatment Follow-up Visit | Mild | 5 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at Treatment Discontinuation | None | 12 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain at Dressing Removal Overall | None | 18 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at Treatment Discontinuation | Mild | 8 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at 7-Day Post Treatment Follow-up Visit | Moderate | 1 Wounds |
| NPWT (Grafted Sites) | Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Level of Pain in the Past Week at Treatment Discontinuation | Moderate | 1 Wounds |