Trial Outcomes & Findings for Evaluation of the Use of EZCare/V1STA in the Management of Acute and Chronic Wounds (NCT NCT00994162)

Last Updated: 2022-09-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

153 participants

Primary outcome timeframe

Baseline

Results posted on

2022-09-21

Participant Flow

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.

A total of 153 subjects were enrolled; however, one V1STA subject was withdrawn from the study due to medical complications that prohibited the application of the NPWT system.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.

Participant milestones

Participant milestones
Measure	Negative Pressure Wound Therapy Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.
Overall Study STARTED	153
Overall Study Participants Receiving Treatment	152
Overall Study COMPLETED	125
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Negative Pressure Wound Therapy Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	2
Overall Study Product Complaint	1
Overall Study Poor Compliance	5
Overall Study Lack of Response	3
Overall Study Discharged from Hospital	4
Overall Study Death	2
Overall Study Care Transferred to Another Physician	2
Overall Study Discontinued and Changed to Iodoflex	1
Overall Study Physician Decision	2
Overall Study Surrounding Wound Erythematous	1
Overall Study Machine Losing Vaccum	1
Overall Study Patient Lived Too Far Away	1
Overall Study Above Knee Amputation	1
Overall Study Reason Not Reported By Site	1

Baseline Characteristics

Not all sites reported demographics information for all enrolled subjects.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NPWT (Non-Grafted Sites) n=131 Participants 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.	NPWT (Grafted Sites) n=21 Participants 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.	Total n=152 Participants Total of all reporting groups
Medical History Rheumatoid arthritis · Never had the condition	124 Participants n=131 Participants	21 Participants n=21 Participants	145 Participants n=152 Participants
Medical History Osteoarthritis · Current condition	3 Participants n=131 Participants	0 Participants n=21 Participants	3 Participants n=152 Participants
Medical History Osteoarthritis · Prior condition	0 Participants n=131 Participants	0 Participants n=21 Participants	0 Participants n=152 Participants
Age, Continuous	60.5 years of age STANDARD_DEVIATION 16.8 • n=126 Participants • Not all sites reported demographics information for all enrolled subjects.	43.2 years of age STANDARD_DEVIATION 16.2 • n=21 Participants • Not all sites reported demographics information for all enrolled subjects.	58.0 years of age STANDARD_DEVIATION 17.8 • n=147 Participants • Not all sites reported demographics information for all enrolled subjects.
Sex: Female, Male Female	61 Participants n=130 Participants • Not all sites reported demographics information for all enrolled subjects.	5 Participants n=21 Participants • Not all sites reported demographics information for all enrolled subjects.	66 Participants n=151 Participants • Not all sites reported demographics information for all enrolled subjects.
Sex: Female, Male Male	69 Participants n=130 Participants • Not all sites reported demographics information for all enrolled subjects.	16 Participants n=21 Participants • Not all sites reported demographics information for all enrolled subjects.	85 Participants n=151 Participants • Not all sites reported demographics information for all enrolled subjects.
Treatment Setting Long-term care/nursing home	3 Participants n=131 Participants	0 Participants n=21 Participants	3 Participants n=152 Participants
Treatment Setting Home	29 Participants n=131 Participants	2 Participants n=21 Participants	31 Participants n=152 Participants
Treatment Setting Hospital	76 Participants n=131 Participants	19 Participants n=21 Participants	95 Participants n=152 Participants
Treatment Setting Wound Clinic	23 Participants n=131 Participants	0 Participants n=21 Participants	23 Participants n=152 Participants
Patient Mobility Walks Unaided	50 Participants n=131 Participants	12 Participants n=21 Participants	62 Participants n=152 Participants
Patient Mobility Walks with Aid	30 Participants n=131 Participants	5 Participants n=21 Participants	35 Participants n=152 Participants
Patient Mobility Walks Unaided/Walks with Aid	0 Participants n=131 Participants	1 Participants n=21 Participants	1 Participants n=152 Participants
Patient Mobility Chair Bound	16 Participants n=131 Participants	2 Participants n=21 Participants	18 Participants n=152 Participants
Patient Mobility Walks with Aid/Chair Bound	1 Participants n=131 Participants	0 Participants n=21 Participants	1 Participants n=152 Participants
Patient Mobility Bed Bound	31 Participants n=131 Participants	1 Participants n=21 Participants	32 Participants n=152 Participants
Patient Mobility Chair Bound/Bed Bound	3 Participants n=131 Participants	0 Participants n=21 Participants	3 Participants n=152 Participants
Medical History Anemia · Current condition	8 Participants n=131 Participants	0 Participants n=21 Participants	8 Participants n=152 Participants
Medical History Anemia · Prior condition	3 Participants n=131 Participants	0 Participants n=21 Participants	3 Participants n=152 Participants
Medical History Anemia · Had condition, current/prior not given	4 Participants n=131 Participants	1 Participants n=21 Participants	5 Participants n=152 Participants
Medical History Anemia · Never had the condition	116 Participants n=131 Participants	20 Participants n=21 Participants	136 Participants n=152 Participants
Medical History Diabetes · Current condition	26 Participants n=131 Participants	4 Participants n=21 Participants	30 Participants n=152 Participants
Medical History Diabetes · Prior condition	2 Participants n=131 Participants	0 Participants n=21 Participants	2 Participants n=152 Participants
Medical History Diabetes · Had condition, current/prior not given	23 Participants n=131 Participants	1 Participants n=21 Participants	24 Participants n=152 Participants
Medical History Diabetes · Never had the condition	80 Participants n=131 Participants	16 Participants n=21 Participants	96 Participants n=152 Participants
Medical History Stroke/cardiovascular accident (CVA) · Current condition	3 Participants n=131 Participants	0 Participants n=21 Participants	3 Participants n=152 Participants
Medical History Stroke/cardiovascular accident (CVA) · Prior condition	7 Participants n=131 Participants	0 Participants n=21 Participants	7 Participants n=152 Participants
Medical History Stroke/cardiovascular accident (CVA) · Had condition, current/prior not given	7 Participants n=131 Participants	0 Participants n=21 Participants	7 Participants n=152 Participants
Medical History Stroke/cardiovascular accident (CVA) · Never had the condition	114 Participants n=131 Participants	21 Participants n=21 Participants	135 Participants n=152 Participants
Medical History Hypertension · Current condition	29 Participants n=131 Participants	2 Participants n=21 Participants	31 Participants n=152 Participants
Medical History Hypertension · Prior condition	2 Participants n=131 Participants	0 Participants n=21 Participants	2 Participants n=152 Participants
Medical History Hypertension · Had condition, current/prior not given	27 Participants n=131 Participants	1 Participants n=21 Participants	28 Participants n=152 Participants
Medical History Hypertension · Never had the condition	73 Participants n=131 Participants	18 Participants n=21 Participants	91 Participants n=152 Participants
Medical History Peripheral vascular disease · Current condition	11 Participants n=131 Participants	0 Participants n=21 Participants	11 Participants n=152 Participants
Medical History Peripheral vascular disease · Prior condition	1 Participants n=131 Participants	0 Participants n=21 Participants	1 Participants n=152 Participants
Medical History Peripheral vascular disease · Had condition, current/prior not given	17 Participants n=131 Participants	1 Participants n=21 Participants	18 Participants n=152 Participants
Medical History Peripheral vascular disease · Never had the condition	102 Participants n=131 Participants	20 Participants n=21 Participants	122 Participants n=152 Participants
Medical History Congestive heart failure · Current condition	4 Participants n=131 Participants	0 Participants n=21 Participants	4 Participants n=152 Participants
Medical History Congestive heart failure · Prior condition	2 Participants n=131 Participants	1 Participants n=21 Participants	3 Participants n=152 Participants
Medical History Congestive heart failure · Had condition, current/prior not given	6 Participants n=131 Participants	0 Participants n=21 Participants	6 Participants n=152 Participants
Medical History Congestive heart failure · Never had the condition	119 Participants n=131 Participants	20 Participants n=21 Participants	139 Participants n=152 Participants
Medical History Rheumatoid arthritis · Current condition	2 Participants n=131 Participants	0 Participants n=21 Participants	2 Participants n=152 Participants
Medical History Rheumatoid arthritis · Prior condition	0 Participants n=131 Participants	0 Participants n=21 Participants	0 Participants n=152 Participants
Medical History Rheumatoid arthritis · Had condition, current/prior not given	5 Participants n=131 Participants	0 Participants n=21 Participants	5 Participants n=152 Participants
Medical History Osteoarthritis · Had condition, current/prior not given	16 Participants n=131 Participants	0 Participants n=21 Participants	16 Participants n=152 Participants
Medical History Osteoarthritis · Never had the condition	112 Participants n=131 Participants	21 Participants n=21 Participants	133 Participants n=152 Participants
Medical History Deep vein thrombosis (DVT) · Current condition	1 Participants n=131 Participants	0 Participants n=21 Participants	1 Participants n=152 Participants
Medical History Deep vein thrombosis (DVT) · Prior condition	1 Participants n=131 Participants	0 Participants n=21 Participants	1 Participants n=152 Participants
Medical History Deep vein thrombosis (DVT) · Had condition, current/prior not given	0 Participants n=131 Participants	0 Participants n=21 Participants	0 Participants n=152 Participants
Medical History Deep vein thrombosis (DVT) · Never had the condition	129 Participants n=131 Participants	21 Participants n=21 Participants	150 Participants n=152 Participants
Medical History Varicose veins · Current condition	2 Participants n=131 Participants	0 Participants n=21 Participants	2 Participants n=152 Participants
Medical History Varicose veins · Prior condition	1 Participants n=131 Participants	0 Participants n=21 Participants	1 Participants n=152 Participants
Medical History Varicose veins · Had condition, current/prior not given	2 Participants n=131 Participants	1 Participants n=21 Participants	3 Participants n=152 Participants
Medical History Varicose veins · Never had the condition	126 Participants n=131 Participants	20 Participants n=21 Participants	146 Participants n=152 Participants
Wound Type Surgical wound	63 Participants n=131 Participants	0 Participants n=21 Participants	63 Participants n=152 Participants
Wound Type Traumatic wound	12 Participants n=131 Participants	0 Participants n=21 Participants	12 Participants n=152 Participants
Wound Type Pressure ulcer	34 Participants n=131 Participants	0 Participants n=21 Participants	34 Participants n=152 Participants
Wound Type Diabetic foot ulcer	15 Participants n=131 Participants	0 Participants n=21 Participants	15 Participants n=152 Participants
Wound Type Leg ulcer	4 Participants n=131 Participants	0 Participants n=21 Participants	4 Participants n=152 Participants
Wound Type Graft site	0 Participants n=131 Participants	21 Participants n=21 Participants	21 Participants n=152 Participants
Wound Type Other wound	3 Participants n=131 Participants	0 Participants n=21 Participants	3 Participants n=152 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	NPWT (Non-Grafted Sites) n=127 Wounds Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.	NPWT (Grafted Sites) n=21 Wounds Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.
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	2 Wounds
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	1 Wounds
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	18 Wounds

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	NPWT (Non-Grafted Sites) n=125 Wounds Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.	NPWT (Grafted Sites) n=21 Wounds Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.
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	1 Wounds
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	1 Wounds
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	0 Wounds
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	1 Wounds
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	0 Wounds
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	0 Wounds
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	4 Wounds
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	13 Wounds
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	1 Wounds

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	NPWT (Non-Grafted Sites) n=123 Wounds Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.	NPWT (Grafted Sites) n=20 Wounds Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.
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	11 Wounds
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	5 Wounds
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	4 Wounds

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	NPWT (Non-Grafted Sites) n=123 Wounds Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.	NPWT (Grafted Sites) n=20 Wounds Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.
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	3 Wounds
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	8 Wounds
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	0 Wounds
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	1 Wounds
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	3 Wounds
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	1 Wounds
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	1 Wounds
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	3 Wounds
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	0 Wounds

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	NPWT (Non-Grafted Sites) n=126 Wounds Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.	NPWT (Grafted Sites) n=20 Wounds Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.
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	4 Wounds
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	16 Wounds
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	0 Wounds
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	0 Wounds

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	NPWT (Non-Grafted Sites) n=112 Wounds Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.	NPWT (Grafted Sites) n=15 Wounds Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.
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	70 percentage of improvement in depth Standard Deviation 42.4
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	38.8 percentage of improvement in depth Standard Deviation 46.9
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	29.1 percentage of improvement in depth Standard Deviation 15.4
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	29.1 percentage of improvement in depth Standard Deviation 15.4

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	NPWT (Non-Grafted Sites) n=123 Participants Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.	NPWT (Grafted Sites) n=20 Participants Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.
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	6 Participants
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	13 Participants
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	1 Participants
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	6 Participants
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	14 Participants
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	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	NPWT (Non-Grafted Sites) n=129 Wounds Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.	NPWT (Grafted Sites) n=16 Wounds Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.
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	2.3 days Standard Deviation 2.1
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	3.1 days Standard Deviation 1.2
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	2.6 days Standard Deviation 0.9
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	—
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	2.8 days Standard Deviation 1.3

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	NPWT (Non-Grafted Sites) n=827 Number of Dressing Changes Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.	NPWT (Grafted Sites) n=36 Number of Dressing Changes Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.
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	14.2 minutes Standard Deviation 8.4

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	NPWT (Non-Grafted Sites) n=813 Wounds Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.	NPWT (Grafted Sites) n=37 Wounds Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.
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	4 Wounds
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	11 Wounds
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	5 Wounds
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	1 Wounds
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	12 Wounds
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	8 Wounds
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	1 Wounds
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	0 Wounds
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	11 Wounds
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	5 Wounds
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	1 Wounds
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	0 Wounds
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	18 Wounds
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	17 Wounds
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	1 Wounds
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	1 Wounds

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	NPWT (Non-Grafted Sites) n=131 Wounds Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.	NPWT (Grafted Sites) n=21 Wounds Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.
Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period Level of Wound Odor at Treatment Discontinuation · Slight	19 Wounds	1 Wounds
Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period Level of Wound Odor at Baseline · None	80 Wounds	18 Wounds
Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period Level of Wound Odor at Baseline · Slight	35 Wounds	3 Wounds
Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period Level of Wound Odor at Baseline · Moderate	10 Wounds	0 Wounds
Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period Level of Wound Odor at Baseline · Strong	6 Wounds	0 Wounds
Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period Level of Wound Odor at Treatment Discontinuation · None	107 Wounds	19 Wounds
Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period Level of Wound Odor at Treatment Discontinuation · Moderate	2 Wounds	0 Wounds
Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period Level of Wound Odor at Treatment Discontinuation · Strong	2 Wounds	0 Wounds
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	15 Wounds
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	1 Wounds
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	0 Wounds
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	0 Wounds

Adverse Events

Negative Pressure Wound Therapy

Serious events: 2 serious events

Other events: 1 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Negative Pressure Wound Therapy n=153 participants at risk Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.
General disorders Natural Causes	0.65% 1/153 • Number of events 1 • Baseline through end of study treatment (30 days of treatment plus 7-day follow-up assessment). 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.
Hepatobiliary disorders Alcoholic Liver Disease	0.65% 1/153 • Number of events 1 • Baseline through end of study treatment (30 days of treatment plus 7-day follow-up assessment). 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.

Other adverse events

Other adverse events
Measure	Negative Pressure Wound Therapy n=153 participants at risk Application of NPWT therapy to the wound EZCare/V1STA Negative Pressure Wound Therapy System: Vacuum Source and dressing kit that generates negative pressure over the wound.
Skin and subcutaneous tissue disorders Peri-wound maceration and inflammation	0.65% 1/153 • Number of events 2 • Baseline through end of study treatment (30 days of treatment plus 7-day follow-up assessment). 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.

Additional Information

Rachael Winter

Smith+Nephew

Phone: +44 1482 673475

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60