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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Pressure Wound Therapy | Experimental | Application of NPWT therapy to the wound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EZCare/V1STA Negative Pressure Wound Therapy System | Device | Vacuum Source and dressing kit that generates negative pressure over the wound. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Wounds Stratified by Wound Area for the Performance of EZCare/V1STA in Terms of Wound Progress Towards Closure in Wounds Deemed Suitable for Treatment With Negative Pressure Wound Therapy (NPWT) - Wound Area (Baseline Measurements) | Evaluation was conducted to determine the extent of wound progression by the use of the NPWT EZCare/V1STA devices. Analysis of the amount of granulation tissue formation, successful management of exudate, and wound progression by reduction in area, volume, and depth were measured to assess improvement in wound healing. The wound was measured to assess wound area at Baseline. | Baseline |
| Number of Wounds Stratified by Change in Wound Area for the Performance of EZCare/V1STA in Terms of Wound Progress Towards Closure in Wounds Deemed Suitable for Treatment With Negative Pressure Wound Therapy (NPWT) - Wound Area (Follow-up Visits) | Evaluation was conducted to determine the extent of wound progression by the use of the NPWT EZCare/V1STA devices. Analysis of wound progression by reduction in area was measured to assess improvement in wound healing. The wound was measured for change in wound area from Baseline compared to study discontinuation/withdrawal (up to 30 days of treatment plus a 7-day follow-up visit after discontinuation of NPWT). | Baseline to Treatment Discontinuation (up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation) |
| Number of Wounds Stratified by Wound Volume for the Performance of EZCare/V1STA in Terms of Wound Progress Towards Closure in Wounds Deemed Suitable for Treatment With NPWT - Wound Volume (Baseline Measurements) | Evaluation was conducted to determine the extent of wound progression by the use of the NPWT EZCare/V1STA devices. Analysis of the amount of granulation tissue formation, successful management of exudate, and wound progression by reduction in area, volume, and depth were measured to assess improvement in wound healing. The wound was measured for wound volume at Baseline. | Baseline |
| Number of Wounds Stratified by Change in Wound Volume for the Performance of EZCare/V1STA in Terms of Wound Progress Towards Closure in Wounds Deemed Suitable for Treatment With NPWT - Wound Volume (Follow-up Visits) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond M Dunn, MD | UMass Memorial Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9188971 | Background | Argenta LC, Morykwas MJ. Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg. 1997 Jun;38(6):563-76; discussion 577. | |
| 12572233 | Background | Banwell PE, Teot L. Topical negative pressure (TNP): the evolution of a novel wound therapy. J Wound Care. 2003 Jan;12(1):22-8. doi: 10.12968/jowc.2003.12.1.26451. |
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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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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 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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | NPWT (Grafted Sites) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Not all sites reported demographics information for all enrolled subjects. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Units | Wounds | Baseline | Wounds | Wounds |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Natural Causes | General disorders | Systematic Assessment | Investigator stated death was expected due to age and comorbidities, not related to the product. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peri-wound maceration and inflammation | Skin and subcutaneous tissue disorders | Systematic 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. This was a non-controlled study delivering a global dataset with potential bias towards North America. V1STA was set up as a global study and EZCare was focused on the USA and Canada. This resulted in 108 of the 153 patients being from North America.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachael Winter | Smith+Nephew | +44 1482 673475 | rachael.winter@smith-nephew.com |
Not provided
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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|
Evaluation was conducted to determine the extent of wound progression by the use of the NPWT EZCare/V1STA devices. Analysis of the amount of wound progression by reduction in volume was measured to assess improvement in wound healing. The wound was measured for change in wound volume from Baseline compared to study treatment discontinuation/withdrawal (up to 30 days of treatment plus a 7-day follow-up visit after discontinuation of NPWT). |
| Baseline to Treatment Discontinuation (up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation) |
| Number of Wounds Stratified by Wound Depth for the Performance of EZCare/V1STA in Terms of Wound Progress Towards Closure in Wounds Deemed Suitable for Treatment With NPWT - Wound Depth (Baseline Measurements) | Evaluation was conducted to determine the extent of wound progression by the use of the NPWT EZCare/V1STA devices. Analysis of wound progression by reduction in depth was measured to assess improvement in wound healing. The wound was measured for wound depth at Baseline. | Baseline |
| Number of Wounds Stratified by Improvement in Wound Depth for the Performance of EZCare/V1STA in Terms of Wound Progress Towards Closure in Wounds Deemed Suitable for Treatment With NPWT - Wound Depth (Follow-up Visits) | Evaluation was conducted to determine the extent of wound progression by the use of the NPWT EZCare/V1STA devices. Analysis of wound progression by improvement in depth was measured to assess improvement in wound healing. The wound was measured for change in depth from Baseline to study treatment discontinuation/withdrawal. | Baseline up to 20 weeks post initial treatment |
| Up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation |
| Number of Wounds Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Duration of Wear Time | Evaluation of the general performance characteristics included ease of application and removal, duration of wear time, and time for each dressing change were assessed. Duration of wear time was assessed based on the Baseline level of exudate. | Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation |
| Number of Dressing Changes Stratified by General Performance Characteristics Assessed for EZCare/V1STA NPWT - Time for Each Dressing Change | Evaluation of the general performance characteristics included ease of application and removal, duration of wear time, and time for each dressing change were assessed. Based on the number of dressing changes performed throughout the study on all enrolled subjects, the average time it took to change each dressing was analyzed. | Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation |
| Number of Wounds Stratified by Pain Level for the Analysis of Wound Pain Over the Treatment Period | Evaluation of wound pain was determined by assessing pain over the treatment period (unrelated to dressing application or removal). | Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation |
| Number of Wounds Stratified by Level of Odor for Analysis Over the Treatment Period | Evaluation of wound odor was assessed over the duration of the treatment period at each respective time point. | Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation |
| 12579098 | Background | Luckraz H, Murphy F, Bryant S, Charman SC, Ritchie AJ. Vacuum-assisted closure as a treatment modality for infections after cardiac surgery. J Thorac Cardiovasc Surg. 2003 Feb;125(2):301-5. doi: 10.1067/mtc.2003.74. |
| Poor Compliance |
|
| Lack of Response |
|
| Discharged from Hospital |
|
| Death |
|
| Care Transferred to Another Physician |
|
| Discontinued and Changed to Iodoflex |
|
| Physician Decision |
|
| Surrounding Wound Erythematous |
|
| Machine Losing Vaccum |
|
| Patient Lived Too Far Away |
|
| Above Knee Amputation |
|
| Reason Not Reported By Site |
|
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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years of age |
|
| Sex: Female, Male | Not all sites reported demographics information for all enrolled subjects. | Count of Participants | Participants |
|
| Treatment Setting | Count of Participants | Participants |
|
| Patient Mobility | Count of Participants | Participants |
|
| Medical History | Count of Participants | Participants |
|
| Wound Type | Count of Participants | 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. |
| OG001 | NPWT (Grafted Sites) | 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. |
|
|
| 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). | 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. | Posted | Count of Units | Wounds | Baseline to Treatment Discontinuation (up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation) | Wounds | 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. | 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. | Posted | Count of Units | Wounds | Baseline | Wounds | 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). | 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. | Posted | Count of Units | Wounds | Baseline to Treatment Discontinuation (up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation) | Wounds | 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. | 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. | Posted | Count of Units | Wounds | Baseline | Wounds | Wounds |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | days | Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation | Wounds | 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. | 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. | Posted | Mean | Standard Deviation | minutes | Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation | Number of Dressing Changes | Number of Dressing Changes |
|
|
|
| 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). | 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. | Posted | Count of Units | Wounds | Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation | Wounds | Wounds |
|
|
|
| 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. | 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. | Posted | Count of Units | Wounds | Baseline up to 30 days of treatment plus an additional 7-day follow-up visit after treatment discontinuation | Wounds | 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. | 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. | Posted | Mean | Standard Deviation | percentage of improvement in depth | Baseline up to 20 weeks post initial treatment | Wounds | Wounds |
|
|
|
| 2 |
| 153 |
| 2 |
| 153 |
| 1 |
| 153 |
|
| Alcoholic Liver Disease | Hepatobiliary disorders | Systematic Assessment | Investigator reported multiorgan failure due to alcoholic liver disease, not related to the product. |
|
Not provided
| Had condition, current/prior not given |
|
| Never had the condition |
|
| Prior condition |
|
| Had condition, current/prior not given |
|
| Never had the condition |
|
| Prior condition |
|
| Had condition, current/prior not given |
|
| Never had the condition |
|
| Prior condition |
|
| Had condition, current/prior not given |
|
| Never had the condition |
|
| Prior condition |
|
| Had condition, current/prior not given |
|
| Never had the condition |
|
| Prior condition |
|
| Had condition, current/prior not given |
|
| Never had the condition |
|
| Prior condition |
|
| Had condition, current/prior not given |
|
| Never had the condition |
|
| Prior condition |
|
| Had condition, current/prior not given |
|
| Never had the condition |
|
| Prior condition |
|
| Had condition, current/prior not given |
|
| Never had the condition |
|
| Prior condition |
|
| Had condition, current/prior not given |
|
| Never had the condition |
|
|
| Wound Progression at Treatment Discontinuation by Baseline Wound Area 10 cm^2 to <20 cm^2 |
|
|
| Wound Progression at Treatment Discontinuation by Baseline Wound Area >= 20 cm^2 |
|
|
| >= 100 cm^3 wound volume |
|
|
| Wound Progression at Treatment Discontinuation by Baseline Wound Volume 20 cm^3 to <100 cm^3 |
|
|
| Wound Progression at Treatment Discontinuation by Baseline Wound Volume >= 100 cm^3 |
|
|
| 4 cm to <8 cm wound depth |
|
| >= 8 cm wound depth |
|
| Dissatisfied |
|
| Ease of Removal of Dressing |
|
|
| Baseline Level of Exudate - Mild (duration of wear time) |
|
|
| Baseline Level of Exudate - Moderate (duration of wear time) |
|
|
| Baseline Level of Exudate - Heavy (duration of wear time) |
|
|
| Overall Duration of Wear Time by Level of Exudate |
|
|
|
| Level of Pain in the Past Week at Treatment Discontinuation |
|
|
| Level of Pain in the Past Week at 7-Day Post Treatment Follow-up Visit |
|
|
| Level of Pain at Dressing Removal Overall |
|
|
|
| Level of Wound Odor at Treatment Discontinuation |
|
|
| Level of Wound Odor at 7-Day Post Treatment Follow-up Visit |
|
|
|
| Wound Duration 1 - <4 Weeks |
|
|
| Wound Duration 4 - <20 Weeks |
|
|
| Wound Duration >=20 Weeks |
|
|
| Not progressing to closure/healing |
|
| Not progressing to closure/healing |
|
| Not progressing to closure/healing |
|
| Not progressing to closure/healing |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Strong |
|
| Moderate |
|
| Strong |
|